Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

NCT02943746 | Completed DMC

• 1 other identifier: H-38611
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.

Conditions

Premature Infants

Keywords

Standard Protein Diet; High Protein Diet; Growth; Body Composition; Extremely Low Birth Weight; Human Milk Derived Fortifier; Protein; Targeted Fortification; Human Milk Diet; Prematurity

Outcome Measures

Primary Outcomes (1)

• Linear growth measured using an premature infant length board

  Linear growth will be measured in centimeters (cm) per week. An average weekly linear growth will be calculated for each patient over the study period.These values will be compared to published standards for age.

  Weekly until 35-36 postmenstrual age (PMA)

Secondary Outcomes (1)

• Body composition measured by dual energy x-ray absorptiometry

  Performed at 35-36 weeks postmenstrual age

Study Arms (2)

Control Group (Standard Protein Diet)

ACTIVE COMPARATOR

Infants will receive a standard feeding regimen which consists of mother's own milk or donor human milk (DHM) with DHM derived fortifier. Once daily, a 24 hour batch of human milk is prepared for each infant (standard practice). A 2.5 mL sample will be analyzed for calories, protein, fat, and carbohydrates. Based on the amount of protein in the milk, fortification of feeds with donor human milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day of protein. Data will be recorded for milk analysis, nutrition, and infant growth. The diet will be continued until approximately 35 to 36 weeks postmenstrual age at which point a DXA scan will be performed. A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed. Anthropometrics: weekly weight, length, and head circumference by trained research nurse.

Dietary Supplement: Standard Protein Diet

Intervention Group (High Protein Diet)

EXPERIMENTAL

The intervention group will receive the same standard feeding regimen with the addition of extra milk fortification to give a high protein diet. Human milk will be prepared and analyzed in the same method as the control group. Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day. The diet will be continued until approximately 35 to 36 weeks PMA at which point a DXA scan will be performed. Infants will have 3 sets of labs. A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed. Anthropometrics: weekly weight, length, and head circumference by trained research nurse.

Dietary Supplement: High Protein Diet

Interventions

Standard Protein Diet DIETARY_SUPPLEMENT

Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day.

Control Group (Standard Protein Diet)

High Protein Diet DIETARY_SUPPLEMENT

Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day.

Intervention Group (High Protein Diet)

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Birth weight 500-1000 grams
• Reasonable expectation of survival for study duration (36 weeks postmenstrual age)
• Achieve any enteral feedings by 14 days of life
• Born at our institution or transferred from another institution within the first 24 hours of life and receive an exclusive human milk protein diet (mother's milk supplemented with donor human milk and donor human milk derived fortifier)

You may not qualify if:

• Birth weight \> 1000 grams
• Less than a reasonable expectation for survival for the study duration, enrolled in another clinical study that affects nutritional management
• Failure to achieve enteral feeds by 14 days of life
• Major congenital anomalies or clinically significant congenital heart disease, presence of intestinal perforation or Stage 2 NEC prior to tolerating fortified feeds
• Early transfer to a non-study institution
• Unable to participate in the study for any reason based on decision of study investigator

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Hair AB, Peluso AM, Hawthorne KM, Perez J, Smith DP, Khan JY, O'Donnell A, Powers RJ, Lee ML, Abrams SA. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med. 2016 Mar;11(2):70-4. doi: 10.1089/bfm.2015.0134. Epub 2016 Jan 20.

  PMID: 26789484 BACKGROUND

• Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.

  PMID: 25130571 BACKGROUND

• Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants </= 1250 grams birth weight. BMC Res Notes. 2013 Nov 13;6:459. doi: 10.1186/1756-0500-6-459.

  PMID: 24220185 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amy B Hair, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 25, 2016
• Study Start: November 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)