NCT01891279

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2013

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

May 1, 2012

Last Update Submit

May 4, 2021

Conditions

Short Bowel Syndrome

Keywords

short bowel syndromeElemental formulapartially hydrolyzed formulaEnteral feedingTPN dependencyIntestinal adaptationTPN cholestasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Length of hospital stay

    from birth (admission) to discharge (up to 1 year of age)

  • Direct bilirubin levels

    From birth (admission) to discharge (up to 1 year of age)

  • Blood stream infections

    From birth (admission) to discharge (up to 1 year of age)

Study Arms (2)

elemental formula, Elecare®

EXPERIMENTAL

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

Other: elemental formula Elecare®

part hydrolyzed formula, Pregestimil®

EXPERIMENTAL

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

Other: partially hydrolyzed formula

Interventions

elemental formula Elecare®OTHER

Babies will be randomized to received either elemental formula (Elecare®) or partially hydrolyzed formula (Pregestimil®) if breast milk is not available.

Also known as: Elecare®
elemental formula, Elecare®
partially hydrolyzed formulaOTHER

Babies will be randomized to received either partially hydrolyzed formula (Pregestimil®) or elemental formula (Elecare®)if breast milk is not available.

Also known as: Pregestimil®
part hydrolyzed formula, Pregestimil®

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (11)

  • 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.

    PMID: 8614614BACKGROUND

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

    PMID: 8780910BACKGROUND

  • 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.

    PMID: 12453276BACKGROUND

  • 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.

    PMID: 9481624BACKGROUND

  • 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.

    PMID: 2634733BACKGROUND

  • 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.

    PMID: 1486247BACKGROUND

  • 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.

    PMID: 11445790BACKGROUND

  • 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.

    PMID: 15812462BACKGROUND

  • 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.

    PMID: 15921697BACKGROUND

  • 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.

    PMID: 12730862BACKGROUND

  • 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.

    PMID: 11113071BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

pregestimil

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amir M Khan, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 1, 2012

First Posted

July 3, 2013

Study Start

September 26, 2011

Primary Completion

August 13, 2013

Study Completion

September 17, 2013

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

US(1)