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

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.

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