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Trial registered on ANZCTR
Registration number
ACTRN12610000443099
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
1/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Optimising the protein and energy content of human milk feeds to improve the growth of preterm infants - A Randomised Control Trial (RCT)
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Scientific title
Targeting human milk fortification to achieve preterm infant growth targets - A RCT
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Secondary ID [1]
251911
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nil
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Universal Trial Number (UTN)
U1111-1115-4183
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Growth restriction in preterm infants at discharge
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Condition category
Condition code
Diet and Nutrition
4798
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0
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Other diet and nutrition disorders
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Reproductive Health and Childbirth
257604
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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
Intervention: Fortifying human milk based on the macronutrient composition of milk, measured using mid-infrared technology.
Milk is fortified using human milk fortifier (HMF), a whey protein supplement and a carbohydrate and fat (energy) supplement. The amount of fortifier added to milk feeds depends on the macronutrient composition of the milk and targets recommended protein and energy intakes (Tsang et al. 2005). The intervention is administered throughout the period of time an infant receives fortified feeds. Fortified milk feeds commence at the discretion of the neonatologist, according to the Unit's standard enteral feeding practice, and continue until discharge, unless clinically contraindicated.
Standard enteral feeding practice incorporates 3 stages and two levels of feeds:
Stage 1. Unfortified milk is fed until infants tolerate between 100 and 150 mL/kg/d.
Stage 2. Milk is fortified to Level 1 - this level targets recommended protein and energy intakes within volumes of 160-180 mL/kg/d.
Stage 3. (only for fluid restricted infants who are tolerating Level 1, who receive less than or equal to 150 mL/kg/d and who demonstrate poor growth). Milk is fortified to Level 2 - this level targets recommended protein and energy intakes within volumes of 130-150 mL/kg/d.
REFERENCE
Tsang RC, Uauy R, Koletzko B, Zlotkin SH (eds). Nutrition of the preterm infant. Scientific basis and practical guidelines. 2nd Ed. Cincinnati, Ohio: Digital Educational Publishing.
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Intervention code [1]
4269
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Treatment: Other
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Comparator / control treatment
There is one control arm in this trial. The control group receives routine fortification according to standard enteral feeding practice, based on assumed milk composition, within the same time-frame as the intervention.
Routine fortification is as follows:
Level 1 fortification: 2 sachets of HMF are added per 100 mL of milk to provide an additional 1.0 g protein.
Level 2 fortification - As per Level 1, with an additional 0.5 g of a whey protein supplement and 2.5 g of an energy supplement per 100 mL of milk.
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Control group
Active
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Outcomes
Primary outcome [1]
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Body composition measured with air displacement - Peapod
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Assessment method [1]
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Timepoint [1]
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Discharge and term corrected gestational age (cGA).
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Primary outcome [2]
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Weight (scales), length (length board) and head circumference (non-stretchable measuring tape).
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Assessment method [2]
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Timepoint [2]
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Birth, discharge and term cGA.
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Secondary outcome [1]
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Body composition measured with ultrasound.
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Assessment method [1]
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Timepoint [1]
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From birth and every 3rd week until term cGA.
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Eligibility
Key inclusion criteria
Preterm infants < 30 weeks gestation
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Minimum age
23
Weeks
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Maximum age
29
Weeks
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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
Infants born with congenital abnormalities.
Maternal intention to formula feed.
Living outside the metropolitan area (if this results in the infant being unable to attend the term follow-up assessment).
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Study design
Purpose of the study
Treatment
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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)
Informed consent will be obtained from the primary carer at birth. After obtaining informed parenteral consent, the eligible infants will be allocated to the intervention or control using coded, sealed, opaque and serially numbered envelopes. Allocation concealment will be optimised by entering the basic demographic data before opening the envelope to determine the type of intervention assignment for each infant.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation rule was applied - random draw, without replacement.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/01/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian Rotary Health
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Address [1]
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Rotary Down Under House
3rd Floor
43 Hunter Street
Parramatta NSW 2124
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Western Australia
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Address
35 Stirling Highway
Nedlands WA 6009
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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King Edward Memorial Hospital
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Address [1]
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Neonatal Clinical Care Unit
Level 1 A Block
374 Bagot Road
Subiaco WA 6008
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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King Edward Memorial Hospital Ethics Committee
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Ethics committee address [1]
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c/- Princess Margaret Hospital (PMH) for Children
GPO Box D184 Perth WA 6840
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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05/08/2008
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Ethics approval number [1]
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1551/EW
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Summary
Brief summary
Preterm infants < 30 weeks gestation will be randomised to either receive targeted fortification of human milk based on measured macronutrient composition or routine fortification of human milk based on assumed macronutrient composition. Nutrition intakes, growth and body composition will be the outcome measures.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Karen Simmer
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Address
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Level 1 A Block
King Edward Memorial Hospital
Neonatal Clinical Care Unit
374 Bagot Road,
Subiaco WA 6008
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Country
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Australia
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Phone
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61 8 9340 1262
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Fax
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61 8 9340 1266
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Email
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[email protected]
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Contact person for scientific queries
Name
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Karen Simmer
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Address
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King Edward Memorial Hospital
Neonatal Clinical Care Unit
Level 1 A Block
374 Bagot Road,
Subiaco WA 6008
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Country
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Australia
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Phone
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61 8 9340 1262
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Fax
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61 8 9340 1266
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth a randomised controlled trial.
2016
https://dx.doi.org/10.1017/S0007114515004614
N.B. These documents automatically identified may not have been verified by the study sponsor.
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