Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
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|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
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Other: elemental formula Elecare® Other: partially hydrolyzed formula||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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®
- 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.
- 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
- 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
- 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.
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
|Contact: See W Chan, MD, MPHfirstname.lastname@example.org|
|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 email@example.com|
|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|
|Principal Investigator:||See W Chan, MD, MPH||The University of Texas Health Science Center, Houston|