Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001275954
Ethics application status
Approved
Date submitted
9/12/2011
Date registered
12/12/2011
Date last updated
5/03/2021
Date data sharing statement initially provided
5/03/2021
Date results provided
5/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does increasing the protein content of human milk fortifier improve growth in preterm infants <33 weeks gestation? A randomised controlled trial.
Scientific title
In infants <33 weeks gestation, does higher protein human milk fortifier compared to standard protein human milk fortifier improve weight gain?
Secondary ID [1] 273347 0
Nil
Universal Trial Number (UTN)
U1111-1125-7043
Trial acronym
POPPET - Providing Optimal Protein for Prems via Enteral Tubes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature infant growth 279115 0
Condition category
Condition code
Diet and Nutrition 279307 279307 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Human milk fortifier is given as standard clinical practice to preterm infants, increasing the protein content by 1g/100ml breast milk. This intervention will add an additional 0.8g protein/100ml breast milk, thus intervention infants will receive 1.8g protein/100ml breast milk and 25 cal/30 ml.
The intervention will begin when the attending clinician prescribes the infant fortifier. Fortifier is given with all expressed breast milk feeds and this will be the case for this study. The study will cease at discharge or estimated delivery date, whichever occurs first.
Intervention code [1] 283689 0
Treatment: Other
Comparator / control treatment
Control infants receive standard protein fortification, ie they will receive 1g protein/100ml breast milk. The human milk fortifier will be made isocaloric.
Control group
Active

Outcomes
Primary outcome [1] 279918 0
Weight gain. Infants will be weighed weekly and weight gain from study start to discharge home used as primary outcome.
Timepoint [1] 279918 0
Term equivalent or discharge home, whichever occurs first.
Secondary outcome [1] 294777 0
Length and head circumference gain. Infant length and head circumference will be measured weekly from study start to discharge home used as primary outcome.
Timepoint [1] 294777 0
Estimated delivery date or discharge, whichever occurs first.

Eligibility
Key inclusion criteria
Infants <33 completed weeks gestation whose mothers intend to provide breast milk and have the written informed consent of their parents/guardians.
Minimum age
28 Weeks
Maximum age
32 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with major congenital or chromosomal abnormalities known to affect growth or where protein therapy is contraindicated e.g. major heart defects, cystic fibrosis, phenylketonuria, disorders of the urea cycle. Infants likely to transfer to remote locations where weekly blood tests are unable to be performed.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon consent, infants will be randomised to either treatment (high protein) or control (standard protein) and assigned a unique study ID. Each dietary treatment (high protein group, standard protein group) will be split into two coded groups (hence a total of four coded groups). Allocation will involve contacting the holder of the allocation schedule who is at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule using variable block design will be generated by statisticians independent of study conduct. Stratification will occur for sex and gestational age <30 weeks and 30 to 32 weeks.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2012
Actual
23/02/2012
Date of last participant enrolment
Anticipated
Actual
1/04/2013
Date of last data collection
Anticipated
Actual
2/09/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 284173 0
Self funded/Unfunded
Name [1] 284173 0
Women's and Children's Health Research Institute
Country [1] 284173 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road
North Adelaide
South Australia 5006
Country
Australia
Secondary sponsor category [1] 269127 0
None
Name [1] 269127 0
Address [1] 269127 0
Country [1] 269127 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286314 0
Women's and Childrens Health Network Human Research Ethics Committee
Ethics committee address [1] 286314 0
72 King William Road
North Adelaide
South Australia 5006
Ethics committee country [1] 286314 0
Australia
Date submitted for ethics approval [1] 286314 0
16/09/2011
Approval date [1] 286314 0
25/11/2011
Ethics approval number [1] 286314 0
REC2401

Summary
Brief summary
Based on the results from our PiPIN trial (REC 1774/12/08, ACTRN12606000525583) - where increasing the protein content of human milk fortifier resulted in a borderline significant increase in length gain (P=0.08) but a significant reduction in SGA for length in preterm infants – we hypothesise a higher level of protein is required to meet the growth needs of preterm infants. In this study we wish to increase the protein fortification to 1.8g protein/100ml breast milk compared with standard fortification 1g/100ml.

A novel aspect of this study is that we will deliver an ‘entrée’ of fortifier directly through the naso-gastric tube rather than mix the fortifier in expressed breast milk as is current practice. Our novel approach allows direct breast feeds to be fortified. Currently when babies feed directly from the breast their feeds are not fortified contributing to the growth deficits seen in breast fed preterm infants.

This study will therefore test the effect of increasing the protein content of human milk fortifier on growth and the feasibility of delivering a fortifier solution directly to the infant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33362 0
Ms Jessica Reid
Address 33362 0
72 King William St
North Adelaide 5006
Country 33362 0
Australia
Phone 33362 0
+61882226000
Fax 33362 0
Email 33362 0
jessica.reid@adelaide.edu.au
Contact person for public queries
Name 16609 0
Jessica Reid
Address 16609 0
Women's and Children's Health Research Institute
72 King William Road
North Adelaide 5006
South Australia
Country 16609 0
Australia
Phone 16609 0
+61 08 8161 6848
Fax 16609 0
Email 16609 0
jessica.reid@adelaide.edu.au
Contact person for scientific queries
Name 7537 0
Jessica Reid
Address 7537 0
Women's and Children's Health Research Institute
72 King William Road
North Adelaide 5006
South Australia
Country 7537 0
Australia
Phone 7537 0
+61 08 8161 6848
Fax 7537 0
Email 7537 0
jessica.reid@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes The Effect of Increasing the Protein Content of Hu... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Effect of Increasing the Protein Content of Human Milk Fortifier to 1.8 g/100 mL on Growth in Preterm Infants: A Randomised Controlled Trial2018https://doi.org/10.3390/nu10050634
N.B. These documents automatically identified may not have been verified by the study sponsor.