This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

Logo

Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

Sponsored by Baylor College of Medicine

About this trial

Last updated 5 months ago

Study ID

H-38611

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

14+ Years
All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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)

Exclusion Criteria

* 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