None listed
Conditions
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.
Interventions
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,
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.
Sponsors
Associate Professor Maria Makrides, Child Nutrition Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 3 Years
Healthy volunteers
No
Inclusion criteria
Infants born <31 weeks gestation at Women's & Children's Hospital Adelaide who are receiving breast milk.
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.
Outcome results
None listed