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

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
elemental formula Elecare®
partially hydrolyzed formula
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Short Bowel Syndrome focused on measuring short bowel syndrome, Elemental formula, partially hydrolyzed formula, Enteral feeding, TPN dependency, Intestinal adaptation, TPN cholestasis

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

elemental formula, Elecare®

part hydrolyzed formula, Pregestimil®

Arm Description

Babies will receive elemental formula, Elecare®, if breast milk is not available.

Babies will receive partially hydrolyzed formula, Pregestimil®, if breast milk is not available.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of hospital stay
number of hospital days from birth to hospital 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
Blood stream infections
Assessment for signs of infection (e.g. CBC, CRP, blood cultures, UA, stool studies, C. diff) is routine.

Full Information

First Posted
May 1, 2012
Last Updated
May 4, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01891279
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2011 (Actual)
Primary Completion Date
August 13, 2013 (Actual)
Study Completion Date
September 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
short bowel syndrome, Elemental formula, partially hydrolyzed formula, Enteral feeding, TPN dependency, Intestinal adaptation, TPN cholestasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
elemental formula, Elecare®
Arm Type
Experimental
Arm Description
Babies will receive elemental formula, Elecare®, if breast milk is not available.
Arm Title
part hydrolyzed formula, Pregestimil®
Arm Type
Experimental
Arm Description
Babies will receive partially hydrolyzed formula, Pregestimil®, if breast milk is not available.
Intervention Type
Other
Intervention Name(s)
elemental formula Elecare®
Other Intervention Name(s)
Elecare®
Intervention Description
Babies will be randomized to received either elemental formula (Elecare®) or partially hydrolyzed formula (Pregestimil®) if breast milk is not available.
Intervention Type
Other
Intervention Name(s)
partially hydrolyzed formula
Other Intervention Name(s)
Pregestimil®
Intervention Description
Babies will be randomized to received either partially hydrolyzed formula (Pregestimil®) or elemental formula (Elecare®)if breast milk is not available.
Primary Outcome Measure Information:
Title
tolerance of TPN use
Description
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.
Time Frame
6 weeks and 8 weeks after initiation of feeding
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
number of hospital days from birth to hospital discharge, up to 1 year of age
Time Frame
from birth (admission) to discharge (up to 1 year of age)
Title
Direct bilirubin levels
Description
The highest and lowest direct bilirubin levels during hospitalization and direct bilirubin level at hospital discharge
Time Frame
From birth (admission) to discharge (up to 1 year of age)
Title
Blood stream infections
Description
Assessment for signs of infection (e.g. CBC, CRP, blood cultures, UA, stool studies, C. diff) is routine.
Time Frame
From birth (admission) to discharge (up to 1 year of age)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir M Khan, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8614614
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.
Results Reference
background
PubMed Identifier
8780910
Citation
Vanderhoof JA. Short bowel syndrome. Clin Perinatol. 1996 Jun;23(2):377-86.
Results Reference
background
PubMed Identifier
12453276
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.
Results Reference
background
PubMed Identifier
9481624
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.
Results Reference
background
PubMed Identifier
2634733
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.
Results Reference
background
PubMed Identifier
1486247
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.
Results Reference
background
PubMed Identifier
11445790
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.
Results Reference
background
PubMed Identifier
15812462
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.
Results Reference
background
PubMed Identifier
15921697
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.
Results Reference
background
PubMed Identifier
12730862
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.
Results Reference
background
PubMed Identifier
11113071
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.
Results Reference
background

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

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