Premature Infant
Conditions
Keywords
Protein supplementation, Human milk fortification
Brief summary
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Detailed description
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group). Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding. Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding. If parent agrees, stool dirty diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
Interventions
DIETARY_SUPPLEMENTHigh protein supplementation
To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive \> 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.
DIETARY_SUPPLEMENTStandard protein supplementation
Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)
Sponsors
Children's Health System, Alabama
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Clinicians and technicians responsible for the assessment of infant body composition will be masked.
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age between 25 and 28 weeks of gestation * Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
Exclusion criteria
* Necrotizing enterocolitis (NEC) stage 2 or greater. * Gastrointestinal or neurologic malformations. * Terminal illness needing to limit or withhold support will be
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant body composition | Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age | Percent body fat estimated by air displacement plethysmography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant body composition | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) | Percent body fat estimated by air displacement plethysmography |
| Growth | Birth to 3 months of corrected age | Weekly weight gain in grams |
| Length | Birth to 3 months of corrected age | Weekly length in cm |
| Head circumference | Birth to 3 months of corrected age | Weekly head circumference in cm |
| Necrotizing enterocolitis | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first | Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3 |
| Death | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first | — |
| Body mass index | Birth to 3 months of corrected age | Weight and height will be combined to report BMI in kg/m\^2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in intestinal microbiome | Birth to 3 months of corrected age | Determined by molecular analyses of bacteria in fecal samples |
| Changes in metabolic pathways | Birth to 3 months of corrected age | Determined by molecular analyses of serum samples |
Countries
United States
Outcome results
None listed