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

The Use of Elemental Formula in Neonates Post Small Bowel Resection: Improved Success to Wean From Total Parenteral Nutrition?

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?

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Other: elemental formula Elecare®; Other: partially hydrolyzed formula

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: elemental formula, Elecare®; Babies will receive elemental formula, Elecare®, if breast milk is not available.	Other: elemental formula Elecare®; Babies will be randomized to received either elemental formula (Elecare®) or partially hydrolyzed formula (Pregestimil®) if breast milk is not available.; Other Names: Elecare®
Experimental: part hydrolyzed formula, Pregestimil®; Babies will receive partially hydrolyzed formula, Pregestimil®, if breast milk is not available.	Other: partially hydrolyzed formula; Babies will be randomized to received either partially hydrolyzed formula (Pregestimil®) or elemental formula (Elecare®)if breast milk is not available.; Other Names: Pregestimil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerance of TPN use	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.	6 weeks and 8 weeks after initiation of feeding

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Amir M Khan, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Vanderhoof JA. Short bowel syndrome. Clin Perinatol. 1996 Jun;23(2):377-86.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2011
• Primary Completion (Actual): August 13, 2013
• Study Completion (Actual): September 17, 2013

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Enteral feeding; short bowel syndrome; Elemental formula; partially hydrolyzed formula; TPN dependency; Intestinal adaptation; TPN cholestasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: HSC-MS-09-0260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No