Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 68 for:    tpn

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01891279
Recruitment Status : Unknown
Verified March 2014 by Chan See Wai, The University of Texas Health Science Center, Houston.
Recruitment status was:  Recruiting
First Posted : July 3, 2013
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Chan See Wai, The University of Texas Health Science Center, Houston

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?

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Other: elemental formula Elecare® Other: partially hydrolyzed formula Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: The Use of Elemental Formula in Neonates Post Small Bowel Resection: Improved Success to Wean From Total Parenteral Nutrition?
Study Start Date : November 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Pregestimil®




Primary Outcome Measures :
  1. tolerance of TPN use [ Time Frame: 6 weeks and 8 weeks after initiation of feeding ]

    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 :
  1. Length of hospital stay [ Time Frame: from birth (admission) to discharge (up to 1 year of age) ]
    number of hospital days from birth to hospital discharge, up to 1 year of age

  2. Direct bilirubin levels [ Time Frame: From birth (admission) to discharge (up to 1 year of age) ]
    The highest and lowest direct bilirubin levels during hospitalization and direct bilirubin level at hospital discharge

  3. Blood stream infections [ Time Frame: From birth (admission) to discharge (up to 1 year of age) ]
    Assessment for signs of infection (e.g. CBC, CRP, blood cultures, UA, stool studies, C. diff) is routine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891279


Contacts
Layout table for location contacts
Contact: See W Chan, MD, MPH 713-500-5845 see.w.chan@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
Children's Memorial Hermann Hosiptal Neonatal Intensive Care Unit Recruiting
Houston, Texas, United States, 77030
Contact: See W Chan, MD, MPH    713-500-5845    see.w.chan@uth.tmc.edu   
Contact: Amir M Khan, MD    713-500-5733    Amir.M.Khan@uth.tmc.edu   
Sub-Investigator: Amir M Khan, MD         
Sub-Investigator: Essam Imseis, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: See W Chan, MD, MPH The University of Texas Health Science Center, Houston

Publications:

Layout table for additonal information
Responsible Party: Chan See Wai, Assistant Professor of Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01891279     History of Changes
Other Study ID Numbers: HSC-MS-09-0260
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Chan See Wai, The University of Texas Health Science Center, Houston:
short bowel syndrome
Elemental formula
partially hydrolyzed formula
Enteral feeding
TPN dependency
Intestinal adaptation
TPN cholestasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Short Bowel Syndrome
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications