Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

Completed · Not applicable

Conditions studied: Premature Infants

In brief

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.

Key facts

Study ID

NCT02943746

Run by

Baylor College of Medicine

People needed

118

Starts

2016-11-01

Expected to finish

2021-04-30

Last updated by the study team

2026-01-29

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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