Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?

Not Applicable

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Other: elemental formula Elecare®; Other: partially hydrolyzed formula

• Registration Number: NCT01891279
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off Total Parenteral Nutrition (TPN) earlier?

Detailed Description

Neonates with short bowel syndrome (SBS) due to recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele) can have inability to adequately digest and absorb enteral feedings resulting in prolonged Parenteral Nutrition (PN) dependence for nutrition and growth. Prolonged PN dependence can result in Parenteral Nutrition Associated Liver Disease (PNALD) and intestinal failure requiring small bowel or small bowel/liver transplantation for survival.

After bowel resection, the bowel has an ability to compensate for significant loss by going through a process called intestinal adaptation. Enteral feeding is the key factor for initiating and maintaining the adaptation of the intestine.

Whole protein formulas or partially hydrolyzed formulas provide either the full protein or dipeptides/tripeptides respectively, and are thought to confer the best benefit in inducing intestinal adaptation and increasing paracrine stimulation. However, in small studies of adults and children with SBS,an amino acid based (elemental) formula demonstrated improved feeding tolerance and ability to wean off TPN. In a small study, babies fed breast milk or elemental formula appeared to have shorter duration of TPN.

This is a randomized, blinded clinical trial to determine if elemental formula, Elecare® (vs. partially hydrolyzed formula, Pregestimil®) is better tolerated and allows a higher proportion of neonates with small bowel resection or congenital bowel anomalies to successfully wean off TPN.

Study Timeline

• Study Start: 2011-09-26
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Primary Completion: 2013-08-13
• Study Completion: 2013-09-17
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Term or pre-term neonates with either surgical resection of the small bowel or congenital bowel anomalies (gastroschisis, omphalocele) unable to tolerate 90kcal/kg/day of enteral feedings by 1 month of age

Exclusion Criteria

• Term or preterm neonates with NEC totalis,
• Inborn Errors of Metabolism, or
• Known or suspected congenital syndromes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
elemental formula, Elecare®	elemental formula Elecare®	Babies will receive elemental formula, Elecare®, if breast milk is not available.
part hydrolyzed formula, Pregestimil®	partially hydrolyzed formula	Babies will receive partially hydrolyzed formula, Pregestimil®, if breast milk is not available.

Primary Outcome Measures

Name	Time	Method
tolerance of TPN use	6 weeks and 8 weeks after initiation of feeding	At 6 wks post intervention, if they are tolerating \< 40 enteral Kcal/k/day, this will be considered a failure to establish adaptation with the formula; if they are tolerating 41-90 enteral Kcal/k/day, this formula will be continued for 2 weeks longer;if they are tolerating \>90 enteral Kcal/k/day, this will be considered a weaning success.; At 8 wks post intervention, if they are tolerating \<90 enteral Kcal/k/day, this will be considered a failure to establish adaptation; At 8 wks post intervention, if they are tolerating \>90 enteral Kcal/k/day, this will be considered a weaning success.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	from birth (admission) to discharge (up to 1 year of age)	number of hospital days from birth to hospital discharge, up to 1 year of age
Direct bilirubin levels	From birth (admission) to discharge (up to 1 year of age)	The highest and lowest direct bilirubin levels during hospitalization and direct bilirubin level at hospital discharge
Blood stream infections	From birth (admission) to discharge (up to 1 year of age)	Assessment for signs of infection (e.g. CBC, CRP, blood cultures, UA, stool studies, C. diff) is routine.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States