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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Other: elemental formula Elecare®
* Other: partially hydrolyzed formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short bowel syndrome, Elemental formula, partially hydrolyzed formula, Enteral feeding, TPN dependency, Intestinal adaptation, TPN cholestasis