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Trial registered on ANZCTR
Registration number
ACTRN12624000289516
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
20/03/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Giving Donor Milk Instead of Formula in Moderate-Late Preterm Infants: the GIFT trial
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Scientific title
Effect of supplementary pasteurised donor human milk compared with infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in moderate and late preterm babies – a randomised controlled trial
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Secondary ID [1]
310950
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
GIFT
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Linked study record
ACTRN12621000529842 is a pilot study that informed this large multi-centre trial.
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Health condition
Health condition(s) or problem(s) studied:
Feeding intolerance
332028
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Condition category
Condition code
Oral and Gastrointestinal
328757
328757
0
0
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Normal oral and gastrointestinal development and function
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Reproductive Health and Childbirth
329838
329838
0
0
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Breast feeding
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Reproductive Health and Childbirth
329839
329839
0
0
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Pasteurised donor human milk provided by Australian Red Cross Lifeblood. All milk will undergo microbiological screening before and after Holder pasteurisation (30 minutes at 62.5°C) according to Lifeblood policies. Mother’s own breast milk will always be given first and if supplementary feeds are required, then study nutrition will be used. Feeds will start at 10-15 ml/kg/day, and increasing 10-15 ml/kg/day or as per clinician discretion. Study nutrition will be provided from the day of randomisation for 15 days or earlier if there is sufficient mother’s own breast milk to support the target fluid intake, or the infant is discharged from hospital, to postnatal ward or transferred to another hospital. A research nurse will monitor fluid balance charts to monitor adherence to the study protocol during the intervention phase.
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Intervention code [1]
327377
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Treatment: Other
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Comparator / control treatment
Infant formula, with the type and brand to be determined by each site. Sites will be using either standard term formula or standard preterm formula routinely used at the site. Mother’s own breast milk will always be given first and if supplementary feeds are required, then study nutrition will be used. Feeds will start at 10-15 ml/kg/day, and increasing 10-15 ml/kg/day or as per clinician discretion. Study nutrition will be provided from the day of randomisation for 15 days or earlier if there is sufficient mother’s own breast milk to support the target fluid intake, or the infant is discharged from hospital, to postnatal ward or transferred to another hospital. A research nurse will monitor fluid balance charts to monitor adherence to the study protocol during the intervention phase.
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Control group
Active
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Outcomes
Primary outcome [1]
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Length of neonatal hospital stay (days)
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Assessment method [1]
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Assessed by data collected from medical records at each site to find the difference between the date of hospital discharge and date of birth
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Timepoint [1]
336562
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At discharge from hospital
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Secondary outcome [1]
431226
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Frequency of feed intolerance
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Assessment method [1]
431226
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Assessed by data collected from medical records at each site to find any recorded enteral feeds that were delayed or stopped for more than 4 hours, excluding feeds held for surgical or radiological procedures, during hospital stay
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Timepoint [1]
431226
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At discharge from hospital
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Secondary outcome [2]
431227
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Time to establish full oral feeds during hospital stay (days)
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Assessment method [2]
431227
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Assessed by data collected from medical records at each site to find the difference between the date when infant reached full enteral feeds of 150ml/kg/day and date of birth
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Timepoint [2]
431227
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At discharge from hospital
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Secondary outcome [3]
431228
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Episodes of hypoglycaemia during hospital stay
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Assessment method [3]
431228
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Assessed by data collected from medical records at each site to find number of recorded episodes of hypoglycaemia during hospital stay measured at <2.5 mmol/L
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Timepoint [3]
431228
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At discharge from hospital
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Secondary outcome [4]
431229
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Frequency of jaundice requiring phototherapy during hospital stay
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Assessment method [4]
431229
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Assessed by data collected from medical records at each site to find any record of jaundice that required phototherapy during hospital stay
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Timepoint [4]
431229
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At discharge from hospital
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Secondary outcome [5]
431230
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Use and duration of supplements
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Assessment method [5]
431230
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Assessed by:
-data collected from medical records at each site to find types and number of days supplements were given to infant during hospital stay, including protein additive, polyjoule, iron, milk thickener, multivitamins and probiotics or prebiotics
- reported by parents via study-specific questionnaire completed electronically or over the phone
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Timepoint [5]
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Data during hospital stay will be collected at discharge from hospital
Data reported by parents will be collected at 2, 4, 6, 12 and 18 month corrected age
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Secondary outcome [6]
431231
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Use and duration of parenteral nutrition during hospital stay
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Assessment method [6]
431231
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Assessed by data collected from medical records at each site to find the number of days parenteral nutrition solutions (PNS) was given to infant during hospital stay
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Timepoint [6]
431231
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At discharge from hospital
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Secondary outcome [7]
431232
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Duration of IV Glucose/Dextrose during hospital stay
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Assessment method [7]
431232
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Assessed by data collected from medical records at each site to find the number of days IV glucose/dextrose with or without electrolytes was given to infant during hospital stay
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Timepoint [7]
431232
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At discharge from hospital
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Secondary outcome [8]
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Type of feeding methods including Nasogastric Tube during hospital stay. This will be assessed separately.
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Assessment method [8]
431679
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Assessed separately by data collected from medical records at each site for feeding methods used to deliver feeds to infant during hospital stay including direct breastfeeding, bottle, Nasogastric Tube and finger feeding
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Timepoint [8]
431679
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At discharge from hospital
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Secondary outcome [9]
431683
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Proven late onset sepsis during hospital stay
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Assessment method [9]
431683
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Assessed by data collected from medical records at each site of recorded proven late onset sepsis 48 hours after birth during hospital stay
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Timepoint [9]
431683
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At discharge from hospital
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Secondary outcome [10]
431685
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Proven necrotising enterocolitis during hospital stay
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Assessment method [10]
431685
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Assessed by data collected from medical records at each site of recorded proven necrotising enterocolitis Bell's stage 2 or higher during hospital stay
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Timepoint [10]
431685
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At discharge from hospital
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Secondary outcome [11]
431690
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Diagnoses and conditions
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Assessment method [11]
431690
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Assessed by data collected from medical records at each site and reported by parents of any diagnoses and conditions confirmed for infant via study-specific questionnaire completed electronically or over the phone
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Timepoint [11]
431690
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At discharge from hospital and at 2, 4, 6, 12 and 18 months corrected age
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Secondary outcome [12]
431692
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Frequency of breastfeeding
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Assessment method [12]
431692
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Assessed by data collected from medical records at each site and reported by parents of any and/or exclusive breastfeeding for infant via study-specific questionnaire completed electronically or over the phone
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Timepoint [12]
431692
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At discharge from hospital and at 2, 4, 6, 12 and 18 months corrected age
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Secondary outcome [13]
431693
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Self-reported breastfeeding challenges, use of medications and foods or ingredients to boost breast milk supply and type of feeding methods used. This will be assessed separately.
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Assessment method [13]
431693
0
Assessed by data reported by parents via study-specific questionnaire completed electronically or over the phone
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Timepoint [13]
431693
0
At discharge from hospital and at 2, 4 and 6 months corrected age
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Secondary outcome [14]
431696
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Mean fat free mass percentage of total body mass
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Assessment method [14]
431696
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Assessed by body composition measurements from PEA POD machine performed during study visits
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Timepoint [14]
431696
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At discharge from hospital and at 4 months corrected age in select sites
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Secondary outcome [15]
431698
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Mean total body fat percentage
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Assessment method [15]
431698
0
Assessed by body composition measurements from PEA POD machine performed during study visits
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Timepoint [15]
431698
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At discharge from hospital and at 4 months corrected age in select sites
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Secondary outcome [16]
431699
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Time to regain birth weight (days)
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Assessment method [16]
431699
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Assessed by data collected from medical records at each site to find the difference between date infant reached equal to or more than birth weight and date of birth
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Timepoint [16]
431699
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At discharge from hospital
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Secondary outcome [17]
431701
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Infant weight z-score for gestational age at discharge
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Assessment method [17]
431701
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Assessed by data collected from medical records at each site of weight measurement (g) recorded at discharge from hospital
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Timepoint [17]
431701
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At discharge from hospital
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Secondary outcome [18]
431702
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Infant length z-score for gestational age at discharge
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Assessment method [18]
431702
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Assessed by data collected from medical records at each site of length measurement (cm) recorded at discharge from hospital
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Timepoint [18]
431702
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At discharge from hospital
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Secondary outcome [19]
431703
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Infant head circumference z-score for gestational age at discharge
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Assessment method [19]
431703
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Assessed by data collected from medical records at each site of head circumference measurement (cm) recorded at discharge from hospital
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Timepoint [19]
431703
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At discharge from hospital
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Secondary outcome [20]
431704
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Weight z-score change from birth to discharge
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Assessment method [20]
431704
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Assessed by data collected from medical records at each site of weight measurements (g) recorded at birth and at discharge from hospital
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Timepoint [20]
431704
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At discharge from hospital
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Secondary outcome [21]
431705
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Length z-score change from birth to discharge
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Assessment method [21]
431705
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Assessed by data collected from medical records at each site of length measurements (cm) recorded at birth and at discharge from hospital
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Timepoint [21]
431705
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At discharge from hospital
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Secondary outcome [22]
431706
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Head circumference z-score change from birth to discharge
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Assessment method [22]
431706
0
Assessed by data collected from medical records at each site of head circumference measurements (cm) recorded at birth and at discharge from hospital
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Timepoint [22]
431706
0
At discharge from hospital
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Secondary outcome [23]
431707
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Weight measurement (g)
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Assessment method [23]
431707
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Assessed by study staff during study visits using regularly calibrated infant weight scales and/or reported by parents via study-specific questionnaire completed electronically or over the phone
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Timepoint [23]
431707
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At 2, 4, 6, 12 and 18 months corrected age
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Secondary outcome [24]
431708
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Frequency of breast milk feeds (including expressed breast milk given via bottle)
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Assessment method [24]
431708
0
Assessed by data collected from medical records at each site and reported by parents of any breast milk feeds given to baby via study-specific questionnaire completed electronically or over the phone
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Timepoint [24]
431708
0
At discharge from hospital and at 2, 4, 6, 12 and 18 months corrected age
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Secondary outcome [25]
431709
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Parent-reported general development
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Assessment method [25]
431709
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Assessed by Ages and Stage Questionnaire, third edition, completed by parents
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Timepoint [25]
431709
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At 12 and 18 months corrected age
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Secondary outcome [26]
431710
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Parent-reported feeding behaviours
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Assessment method [26]
431710
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Assessed by the Eating Behaviour Questionnaire completed by parents
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Timepoint [26]
431710
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At 18 months corrected age
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Secondary outcome [27]
431711
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Parental wellbeing
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Assessment method [27]
431711
0
Assessed by Warwick-Edinburgh Mental Well-being Scale (WEMWBS) completed by mothers at discharge and at 12 months corrected age
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Timepoint [27]
431711
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At discharge and 12 months corrected age
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Secondary outcome [28]
431712
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Ratings of experience of the trial
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Assessment method [28]
431712
0
Assessed through a question completed by parents
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Timepoint [28]
431712
0
At 6 months corrected age
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Secondary outcome [29]
431713
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Care and degree of lactation support during the hospitalisation. This will be assessed as a composite outcome.
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Assessment method [29]
431713
0
Assessed by study-specific questions completed by mothers
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Timepoint [29]
431713
0
At enrolment and at discharge from hospital
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Secondary outcome [30]
431714
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Neonatal length of stay (days) sub-grouped by acuity of care (neonatal intensive care, special care and transitional care) reported separately
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Assessment method [30]
431714
0
Assessed by medical records from each site
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Timepoint [30]
431714
0
At discharge from hospital
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Secondary outcome [31]
431715
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Maternal length of stay in hospital (days)
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Assessment method [31]
431715
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Assessed by medical records from each site
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Timepoint [31]
431715
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At discharge from hospital
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Secondary outcome [32]
431716
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Costs associated with use of donor milk
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Assessment method [32]
431716
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Assessed by data obtained from each site and data from the Australian Red Cross Lifeblood including unit price and staffing required to receive, deliver and track milk
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Timepoint [32]
431716
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During the study period
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Secondary outcome [33]
431717
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Costs associated with the neonatal hospitalisation
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Assessment method [33]
431717
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Assessed by data obtained from each site and from the Independent Hospital Pricing Authority
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Timepoint [33]
431717
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From birth to discharge from hospital
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Secondary outcome [34]
431718
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Costs associated with donor milk provision
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Assessment method [34]
431718
0
Assessed by data obtained from the Australian Red Cross Lifeblood and each site
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Timepoint [34]
431718
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During the study period
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Secondary outcome [35]
431719
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Admission costs by gestational age category
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Assessment method [35]
431719
0
Assessed by data from the Independent Hospital Pricing Authority
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Timepoint [35]
431719
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From birth to discharge from hospital
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Secondary outcome [36]
431720
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Health services utilisation from birth to 18 months corrected age
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Assessment method [36]
431720
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Assessed through linkage to State-based hospitalisation and emergency department records and the Medical Benefits Schedule and Pharmaceutical Benefits Schedule maintained by the Commonwealth
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Timepoint [36]
431720
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Birth to 18 months corrected age
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Secondary outcome [37]
431721
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Safety Adverse Events
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Assessment method [37]
431721
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Assessed by medical records and data reported by the Australian Red Cross Lifeblood of any adverse events defined as an unexpected finding or illness during the neonatal admission that the treating health care team suspects could be due to donor milk resulting in a notification to Lifeblood using the ‘Lifeblood PDHM Adverse Event Reporting form’.
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Timepoint [37]
431721
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During the intervention period
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Secondary outcome [38]
431722
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Safety Serious Adverse Events
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Assessment method [38]
431722
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Assessed by medical records and data reported by the Australian Red Cross Lifeblood of any serious adverse events defined as neonatal death/death in the first 28 days of life reported by health care team or infant death/death of an infant after the first 28 days of life reported by parents.
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Timepoint [38]
431722
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During the study period
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Secondary outcome [39]
431731
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Volume and type of milk feeds during hospital stay. This will be assessed separately.
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Assessment method [39]
431731
0
Assessed by data collected from medical records at each site of recorded feeds given to infant during hospital stay
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Timepoint [39]
431731
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At discharge from hospital
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Secondary outcome [40]
432492
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Parental satisfaction
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Assessment method [40]
432492
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Assessed by Perceived Maternal Parenting Self-Efficacy (PMP S-E tool) completed by mothers at discharge
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Timepoint [40]
432492
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At discharge from hospital
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Eligibility
Key inclusion criteria
- 32+0 and 36+6 completed weeks’ gestation at birth;*
- Birth weight >= 1500g;
- Admitted to the neonatal unit;**
- Clinically stable as determined by the treating physician;
- Ready to commence enteral feeds or commenced enteral feeds with human milk but insufficient maternal breast milk is available as decided by the treating health care team;
- Aged <= 96 hours;
- Has a parent or guardian who is at least 16 years of age and is capable of giving informed consent.
*Only infants with a gestation of >=34 weeks at birth will be enrolled at the Royal Brisbane and Women’s Hospital, this is consistent with the process undertaken in our pilot study.
**If it is anticipated that an infant will be transferred to the postnatal ward or another hospital quickly (e.g. within 8 hours) then they will not be eligible for the study, as for practical reasons the study nutrition will not be able to be administered on the postnatal ward or to non-participating hospitals.
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Minimum age
0
Hours
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Maximum age
96
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Documented, suspected or confirmed metabolic disorder that precludes breastfeeding;
- Major congenital malformation either likely to interfere with the ability to ingest milk or requiring surgery in the first 6 months of life ((including abnormalities of the central nervous system, cardiovascular system, urinary system, gastrointestinal system, chromosomal, metabolic, musculoskeletal, respiratory, diaphragmatic hernia, haematological, tumours or any other unspecified major abnormality);
- Has been given infant formula prior to randomisation.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Infants will be randomly allocated to either the intervention or control group with a 1:1 allocation using a secure web-based randomisation service on the REDCap platform.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule using balanced variable blocks will be prepared by an independent statistician. Stratification will occur for site and gestational age (<34 weeks, >=34 weeks). A computer-generated randomisation schedule using balanced variable block design will be prepared and held by an independent statistician, not otherwise involved in the trial. Twins and triplets will be co-randomised to the same treatment arm.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary outcome of length of neonatal hospital stay will be compared between the randomised groups using a linear regression model with robust variance estimation due to the likely skewed distribution of the data. Adjustment will be made for the stratification variables (gestational age, site) and pre-specified prognostic baseline variables (e.g., multiplicity). Sensitivity analyses will be performed using a linear regression model with bootstrap CIs and a generalised linear model with the distribution and link function informed by the data.
Secondary outcomes will be analysed using linear regression models for continuous outcomes and log binomial regression models for binary outcomes. For infant outcomes, generalised estimating equations will be used to account for clustering due to multiple births. All analyses will follow a pre-specified analysis plan.
Analysis of healthcare costs: The economic value of donor milk for this population will be assessed in terms of cost-savings due to reductions in the risk and severity of neonatal morbidities, and the length of the neonatal hospitalisation. Taking a healthcare system perspective, within-trial incremental costs associated with the two trial arms (including costs associated with the intervention and hospital services) will be estimated. Generalised linear models (GLM) will be fitted to estimate and compare costs between the donor milk and control groups. Goodness of fit will be tested using the modified Park test (for the GLM family) and the Pearson correlation test, the Pregibon link test, and the modified Hosmer and Lemeshow test (for the GLM link). A bootstrapping approach will be applied to represent sampling uncertainty. A costing model will be developed with data from the trial and published literature. This will be used to extrapolate the findings to the national level and assess parameter uncertainty, to predict the costs of alternative scenarios (e.g., current practice vs. expanding access to donor milk to this population).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
25/03/2024
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Actual
27/05/2024
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Date of last participant enrolment
Anticipated
31/12/2027
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Actual
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Date of last data collection
Anticipated
31/12/2029
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Actual
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Sample size
Target
2156
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Accrual to date
9
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Funding & Sponsors
Funding source category [1]
315210
0
Government body
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Name [1]
315210
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National Health and Medical Research Institute (NHMRC)
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Address [1]
315210
0
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Country [1]
315210
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
South Australian Health and Medical Research Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
317817
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None
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Name [1]
317817
0
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Address [1]
317817
0
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Country [1]
317817
0
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Other collaborator category [1]
282954
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Charities/Societies/Foundations
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Name [1]
282954
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Australian Red Cross Lifeblood
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Address [1]
282954
0
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Country [1]
282954
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314135
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Women's and Children's Health Network Human Research Ethics Committee
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Ethics committee address [1]
314135
0
https://www.wchn.sa.gov.au/research/human-research
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Ethics committee country [1]
314135
0
Australia
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Date submitted for ethics approval [1]
314135
0
11/10/2023
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Approval date [1]
314135
0
13/12/2023
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Ethics approval number [1]
314135
0
2023/HRE00241
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Summary
Brief summary
The GIFT Trial is a randomised, controlled, blinded, parallel group trial to compare the effect of supplementary pasteurised donor human milk versus infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in clinically well pre-term infants born between 32+0 and 36+6, with a birth weight >=1500g and with insufficient maternal breast milk available. The GIFT Trial hypothesises that the use of donor milk instead of infant formula, as a supplement to maternal breast milk, in moderate-late preterm infants will reduce the time spent in hospital after birth.
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Trial website
https://sahmri.org.au/research/themes/women-and-kids/programs/pregnancy-and-perinatal-care/projects/the-gift-trial
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Trial related presentations / publications
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Public notes
https://www.adelaide.edu.au/newsroom/news/list/2023/07/31/22m-for-donor-milk-trial-for-pre-term-babies https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/donor-breast-milk-trial-shares-73-million-in-funding https://kiddomag.com.au/featured/the-gift-trial-donor-milk-for-preterm-babies/
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Contacts
Principal investigator
Name
130538
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Prof Alice Rumbold
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Address
130538
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South Australian Health and Medical Research Institute (SAHMRI), 72 King William Road, North Adelaide SA 5006 Australia
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Country
130538
0
Australia
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Phone
130538
0
+61881284194
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Fax
130538
0
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Email
130538
0
[email protected]
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Contact person for public queries
Name
130539
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Alice Rumbold
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Address
130539
0
South Australian Health and Medical Research Institute (SAHMRI), 72 King William Road, North Adelaide SA 5006 Australia
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Country
130539
0
Australia
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Phone
130539
0
+61881284194
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Fax
130539
0
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Email
130539
0
[email protected]
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Contact person for scientific queries
Name
130540
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Alice Rumbold
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Address
130540
0
South Australian Health and Medical Research Institute (SAHMRI), 72 King William Road, North Adelaide SA 5006 Australia
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Country
130540
0
Australia
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Phone
130540
0
+61881284194
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Fax
130540
0
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Email
130540
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
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