Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000525583
Ethics application status
Approved
Date submitted
19/12/2006
Date registered
20/12/2006
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protein in Preterm Infant Nutrition (PiPIN)
Scientific title
A randomised controlled trial on the effects of increasing the protein content of Human Milk Fortifier on growth in preterm infants <31 weeks.
Secondary ID [1] 287898 0
nil known
Universal Trial Number (UTN)
Trial acronym
PiPIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infant < 31 weeks 1499 0
Condition category
Condition code
Reproductive Health and Childbirth 1597 1597 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both the intervention and control group will receive Human Milk Fortifier added to expressed breast milk (EBM) at the rate of 5g fortifier per 100ml EBM. This dose is added to all their breast milk feeds which may be administered as continuous perfusion feeds or one, two or three hourly bolus feeds. The route of administration is oral, usual via a nasogastric tube or sometimes by bottle. The intervention group receives fortifier containing 1.4g protein per 5g. Duration of the treatment is the length of time that fortified human milk is clinically indicated and varies between participants depending on their clinical course. The usual length of the intervention is from the time the infant achieves an enteral intake of 80 - 100ml/kg to the time the infant is graded onto direct sucking feeds from the breast.
Intervention code [1] 1326 0
Treatment: Other
Comparator / control treatment
The control group receives standard fortifier containing 1g protein per 5g
Control group
Dose comparison

Outcomes
Primary outcome [1] 2203 0
Linear growth (increase in recumbent length)
Timepoint [1] 2203 0
Weekly, & Discharge (D/C) or Estimated Date of Delivery (EDD)
Secondary outcome [1] 3840 0
Weight gain: grams
Timepoint [1] 3840 0
Daily, D/C or EDD
Secondary outcome [2] 3841 0
Head circumference: centimetres
Timepoint [2] 3841 0
Weekly, D/C or EDD
Secondary outcome [3] 3842 0
Body composition: Bioelectrical Impedance Spectroscopy
Timepoint [3] 3842 0
Fortnightly D/C or EDD
Secondary outcome [4] 3843 0
Serum albumin, Urea, total protein, electrolytes, acid base
Timepoint [4] 3843 0
Weekly, D/C or EDD
Secondary outcome [5] 3844 0
Amino acid profile (blood & urine): tandem mass spectroscopy
Timepoint [5] 3844 0
Weekly, weekly & D/C or EDD

Eligibility
Key inclusion criteria
Infants born <31 weeks gestation at Women's & Children's Hospital Adelaide who are receiving breast milk.
Minimum age
0 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with major congenital or chromosomal abnormalities which are known to affect growth such as major heart defects, cystic fibrosis.Infants where a high protein intake is contraindicated such as Phenylketonuria, disorders of the urea cycle.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation done by an independent researcher at CNRC using blocked computer generated random numbers. Stratified for gender and gestational age (<28 week, 28 - 30 weeks). Randomisation was implanted via the study product. Tins of fortifier were assigned a number (as above) and placed in 1 of 4 boxes according to stratification. ON recruitment, the researcher went to the appropriate box and took the next sequentially numbered tins.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked computer generated random numbers. Stratified for gender and gestational age (<28 weeks, 28 - 30 weeks)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Partipants, clinicians, assessors and data analyst are blinded to the intervention
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2006
Actual
25/10/2006
Date of last participant enrolment
Anticipated
Actual
3/03/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1741 0
University
Name [1] 1741 0
MS McLeod PhD Scholarship, Women's and Children's Hospital, Adelaide University PhD Divisional Scholarship
Country [1] 1741 0
Australia
Funding source category [2] 3203 0
Other
Name [2] 3203 0
Denis Harwood Grant-in-Aid
Country [2] 3203 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Maria Makrides, Child Nutrition Research Centre
Address
Child Nutrition Research Centre
Children's Youth and Women's Health Service
King William St
North Adelaide South Australia
Country
Australia
Secondary sponsor category [1] 1536 0
Individual
Name [1] 1536 0
Jacqueline Miller
Address [1] 1536 0
Child Nutrition Research Centre,
L4, Flinders Medical Centre,
Bedford Park
Country [1] 1536 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3219 0
Women's and Children's Hospital
Ethics committee address [1] 3219 0
Adelaide
Ethics committee country [1] 3219 0
Australia
Date submitted for ethics approval [1] 3219 0
Approval date [1] 3219 0
20/12/2005
Ethics approval number [1] 3219 0
REC1774/12/08

Summary
Brief summary
Breast milk is best for babies but is inadequate for very preterm infants without fortification with protein and some bone minerals. Currently, all breast milk for very preterm infants is fortified with a 'Human Milk Fortifier' but we're un-sure of the optimum level of protein that should be in the fortifier. This trial aims to determine if a higher level of protein added to fortifier will help preterm infants to grow better.
Trial website
Trial related presentations / publications
J Miller, M Makrides, RA Gibson, AJ McPhee, TE Stanford, S Morris, P Ryan, and CT Collins. Effect of increasing the protein content of human milk fortifier on growth in preterm infants born less than 31 wk gestation: a randomized controlled trial. Am J Clin Nutr 2012 95 (3)
Public notes

Contacts
Principal investigator
Name 27933 0
Dr Jacqui Miller
Address 27933 0
Nutrition and dietetics, Flinders University
Country 27933 0
Australia
Phone 27933 0
+61 8 82045863
Fax 27933 0
Email 27933 0
[email protected]
Contact person for public queries
Name 10515 0
Dr Jacqueline Miller
Address 10515 0
Child Nutrition Research Centre
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5051
Country 10515 0
Australia
Phone 10515 0
+61 8 81618224
Fax 10515 0
+61 8 81618228
Email 10515 0
[email protected]
Contact person for scientific queries
Name 1443 0
Prof Associate Professor Maria Makrides
Address 1443 0
Child Nutrition Research Centre
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5051
Country 1443 0
Australia
Phone 1443 0
+61 8 81616067
Fax 1443 0
+61 8 81618228
Email 1443 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIEffect of increasing protein content of human milk fortifier on growth in preterm infants born at <31 wk gestation: a randomized controlled trial2012https://doi.org/10.3945/ajcn.111.026351
N.B. These documents automatically identified may not have been verified by the study sponsor.