Clinical trial NCT01891279: Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
Official title: The Use of Elemental Formula in Neonates Post Small Bowel Resection: Improved Success to Wean From Total Parenteral Nutrition?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: short bowel syndrome
Elemental formula
partially hydrolyzed formula
Enteral feeding
TPN dependency
Intestinal adaptation
TPN cholestasis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 35
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: tolerance of TPN use
timeFrame: 6 weeks and 8 weeks after initiation of feeding
Secondary outcomes:
measure: Length of hospital stay
timeFrame: from birth (admission) to discharge (up to 1 year of age)
measure: Direct bilirubin levels
timeFrame: From birth (admission) to discharge (up to 1 year of age)
measure: Blood stream infections
timeFrame: From birth (admission) to discharge (up to 1 year of age)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Amir M Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderhoof JA. Short bowel syndrome in children and small intestinal transplantation. Pediatr Clin North Am. 1996 Apr;43(2):533-50. doi: 10.1016/s0031-3955(05)70419-3.
citation: Vanderhoof JA. Short bowel syndrome. Clin Perinatol. 1996 Jun;23(2):377-86.
citation: Bines JE, Taylor RG, Justice F, Paris MC, Sourial M, Nagy E, Emselle S, Catto-Smith AG, Fuller PJ. Influence of diet complexity on intestinal adaptation following massive small bowel resection in a preclinical model. J Gastroenterol Hepatol. 2002 Nov;17(11):1170-9. doi: 10.1046/j.1440-1746.2002.02872.x.
citation: Bines J, Francis D, Hill D. Reducing parenteral requirement in children with short bowel syndrome: impact of an amino acid-based complete infant formula. J Pediatr Gastroenterol Nutr. 1998 Feb;26(2):123-8. doi: 10.1097/00005176-199802000-00001.
citation: Lai HS, Chen WJ, Chen KM, Lee YN. Effects of monomeric and polymeric diets on small intestine following massive resection. Taiwan Yi Xue Hui Za Zhi. 1989 Oct;88(10):982-8.
citation: Cosnes J, Evard D, Beaugerie L, Gendre JP, Le Quintrec Y. Improvement in protein absorption with a small-peptide-based diet in patients with high jejunostomy. Nutrition. 1992 Nov-Dec;8(6):406-11.
citation: Andorsky DJ, Lund DP, Lillehei CW, Jaksic T, Dicanzio J, Richardson DS, Collier SB, Lo C, Duggan C. Nutritional and other postoperative management of neonates with short bowel syndrome correlates with clinical outcomes. J Pediatr. 2001 Jul;139(1):27-33. doi: 10.1067/mpd.2001.114481.
citation: Rhoads JM, Plunkett E, Galanko J, Lichtman S, Taylor L, Maynor A, Weiner T, Freeman K, Guarisco JL, Wu GY. Serum citrulline levels correlate with enteral tolerance and bowel length in infants with short bowel syndrome. J Pediatr. 2005 Apr;146(4):542-7. doi: 10.1016/j.jpeds.2004.12.027.
citation: Jianfeng G, Weiming Z, Ning L, Fangnan L, Li T, Nan L, Jieshou L. Serum citrulline is a simple quantitative marker for small intestinal enterocytes mass and absorption function in short bowel patients. J Surg Res. 2005 Aug;127(2):177-82. doi: 10.1016/j.jss.2005.04.004.
citation: Crenn P, Vahedi K, Lavergne-Slove A, Cynober L, Matuchansky C, Messing B. Plasma citrulline: A marker of enterocyte mass in villous atrophy-associated small bowel disease. Gastroenterology. 2003 May;124(5):1210-9. doi: 10.1016/s0016-5085(03)00170-7.
citation: Crenn P, Coudray-Lucas C, Thuillier F, Cynober L, Messing B. Postabsorptive plasma citrulline concentration is a marker of absorptive enterocyte mass and intestinal failure in humans. Gastroenterology. 2000 Dec;119(6):1496-505. doi: 10.1053/gast.2000.20227.