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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)
Scientific title
Targeting human milk fortification to achieve preterm infant growth targets - A RCT
Secondary ID [1] 251911 0
nil
Universal Trial Number (UTN)
U1111-1115-4183
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth restriction in preterm infants at discharge 257496 0
Condition category
Condition code
Diet and Nutrition 4798 4798 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 257604 257604 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4269 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 5658 0
Body composition measured with air displacement - Peapod
Timepoint [1] 5658 0
Discharge and term corrected gestational age (cGA).
Primary outcome [2] 258518 0
Weight (scales), length (length board) and head circumference (non-stretchable measuring tape).
Timepoint [2] 258518 0
Birth, discharge and term cGA.
Secondary outcome [1] 241544 0
Body composition measured with ultrasound.
Timepoint [1] 241544 0
From birth and every 3rd week until term cGA.

Eligibility
Key inclusion criteria
Preterm infants < 30 weeks gestation
Minimum age
23 Weeks
Maximum age
29 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
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).

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation rule was applied - random draw, without replacement.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257045 0
Charities/Societies/Foundations
Name [1] 257045 0
Australian Rotary Health
Address [1] 257045 0
Rotary Down Under House
3rd Floor
43 Hunter Street
Parramatta NSW 2124
Country [1] 257045 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 256303 0
Hospital
Name [1] 256303 0
King Edward Memorial Hospital
Address [1] 256303 0
Neonatal Clinical Care Unit
Level 1 A Block
374 Bagot Road
Subiaco WA 6008
Country [1] 256303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259055 0
King Edward Memorial Hospital Ethics Committee
Ethics committee address [1] 259055 0
c/- Princess Margaret Hospital (PMH) for Children
GPO Box D184 Perth WA 6840
Ethics committee country [1] 259055 0
Australia
Date submitted for ethics approval [1] 259055 0
Approval date [1] 259055 0
05/08/2008
Ethics approval number [1] 259055 0
1551/EW

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29426 0
Address 29426 0
Country 29426 0
Phone 29426 0
Fax 29426 0
Email 29426 0
Contact person for public queries
Name 12673 0
Karen Simmer
Address 12673 0
Level 1 A Block
King Edward Memorial Hospital
Neonatal Clinical Care Unit
374 Bagot Road,
Subiaco WA 6008
Country 12673 0
Australia
Phone 12673 0
61 8 9340 1262
Fax 12673 0
61 8 9340 1266
Email 12673 0
karen.simmer@health.wa.gov.au
Contact person for scientific queries
Name 3601 0
Karen Simmer
Address 3601 0
King Edward Memorial Hospital
Neonatal Clinical Care Unit
Level 1 A Block
374 Bagot Road,
Subiaco WA 6008
Country 3601 0
Australia
Phone 3601 0
61 8 9340 1262
Fax 3601 0
61 8 9340 1266
Email 3601 0
karen.simmer@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary