## Protocol Section
### Identification Module
**NCT ID:** 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?

#### Organization Study ID Info
**ID:** HSC-MS-09-0260
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2013-09-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-07

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-08-13

**Type:** ACTUAL

#### Start Date
**Date:** 2011-09-26

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2013-07-03
**Type:** ESTIMATED
**Study First Submit Date:** 2012-05-01
**Study First Submit QC Date:** 2013-07-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center, Houston

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center, Houston

**Investigator Full Name:** Amir Mustafa Khan

**Investigator Title:** Professor of Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Short Bowel Syndrome

**Keywords:**

- short bowel syndrome

- Elemental formula

- partially hydrolyzed formula

- Enteral feeding

- TPN dependency

- Intestinal adaptation

- TPN cholestasis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: elemental formula Elecare®

**Label:** elemental formula, Elecare®

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: partially hydrolyzed formula

**Label:** part hydrolyzed formula, Pregestimil®

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- elemental formula, Elecare®

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

**Name:** elemental formula Elecare®

**Other Names:**

- Elecare®

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- part hydrolyzed formula, Pregestimil®

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

**Name:** partially hydrolyzed formula

**Other Names:**

- Pregestimil®

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** tolerance of TPN use

**Time Frame:** 6 weeks and 8 weeks after initiation of feeding

#### Secondary Outcomes

**Description:** number of hospital days from birth to hospital discharge, up to 1 year of age

**Measure:** Length of hospital stay

**Time Frame:** from birth (admission) to discharge (up to 1 year of age)

**Description:** The highest and lowest direct bilirubin levels during hospitalization and direct bilirubin level at hospital discharge

**Measure:** Direct bilirubin levels

**Time Frame:** From birth (admission) to discharge (up to 1 year of age)

**Description:** Assessment for signs of infection (e.g. CBC, CRP, blood cultures, UA, stool studies, C. diff) is routine.

**Measure:** Blood stream infections

**Time Frame:** From birth (admission) to discharge (up to 1 year of age)

### Eligibility Module

**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

**Maximum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** The University of Texas Health Science Center at Houston

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Texas Health Science Center, Houston

**Name:** Amir M Khan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 8614614

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

**PMID:** 8780910

**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.

**PMID:** 12453276

**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.

**PMID:** 9481624

**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.

**PMID:** 2634733

**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.

**PMID:** 1486247

**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.

**PMID:** 11445790

**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.

**PMID:** 15812462

**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.

**PMID:** 15921697

**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.

**PMID:** 12730862

**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.

**PMID:** 11113071

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008286

- Term: Malabsorption Syndromes

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000011183

- Term: Postoperative Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M15586

- Name: Short Bowel Syndrome

- Relevance: HIGH

- As Found: Short Bowel Syndrome

- ID: M6019

- Name: Cholestasis

- Relevance: LOW

- As Found: Unknown

- ID: M11278

- Name: Malabsorption Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: T5206

- Name: Short Bowel Syndrome

- Relevance: HIGH

- As Found: Short Bowel Syndrome

### Condition Browse Module - Meshes

- ID: D000012778

- Term: Short Bowel Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
