Effect of Increased Enteral Protein on Body Composition of Preterm Infants

Premature Infant Clinical Trial

Official title:

Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03586102
• Other study ID #: 300000681
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 2024
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 21 Days

Eligibility

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 exclusion criteria.

Related Conditions & MeSH terms

• Premature Infant

Intervention

Dietary Supplement:
• High 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.
• Standard protein supplementation
Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's Health System, Alabama

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in intestinal microbiome	Determined by molecular analyses of bacteria in fecal samples	Birth to 3 months of corrected age
Other	Changes in metabolic pathways	Determined by molecular analyses of serum samples	Birth to 3 months of corrected age
Primary	Infant body composition	Percent body fat estimated by air displacement plethysmography	Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Secondary	Infant body composition	Percent body fat estimated by air displacement plethysmography	Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Secondary	Growth	Weekly weight gain in grams	Birth to 3 months of corrected age
Secondary	Length	Weekly length in cm	Birth to 3 months of corrected age
Secondary	Head circumference	Weekly head circumference in cm	Birth to 3 months of corrected age
Secondary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	Birth to 3 months of corrected age
Secondary	Necrotizing enterocolitis	Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3	Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Secondary	Death		Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first