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Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

Primary Purpose

Gastroschisis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enteral Intake - Human Milk

Enteral Intake - Formula

About this trial

This is an interventional treatment trial for Gastroschisis

Eligibility Criteria

2 Hours - 48 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1) neonates born with gastroschisis
2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study

Exclusion Criteria:

1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(<1500 grams))
2) known major chromosomal abnormality

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Human Milk

Formula

Arm Description

Neonates fed human milk

Neonates fed formula

Outcomes

Primary Outcome Measures

Length of Hospital Stay

Secondary Outcome Measures

Time to Full Enteral Feeds

Time on Total Parenteral Nutrition

Full Information

NCT ID

NCT02575846

First Posted

October 6, 2015

Last Updated

June 27, 2017

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02575846

Brief Title

Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

Official Title

Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 26, 2015 (Actual)

Primary Completion Date

November 11, 2016 (Actual)

Study Completion Date

November 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroschisis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Human Milk

Arm Type

Active Comparator

Arm Description

Neonates fed human milk

Arm Title

Formula

Arm Type

Placebo Comparator

Arm Description

Neonates fed formula

Intervention Type

Dietary Supplement

Intervention Name(s)

Enteral Intake - Human Milk

Intervention Description

Comparing formula and human milk

Intervention Type

Dietary Supplement

Intervention Name(s)

Enteral Intake - Formula

Intervention Description

Comparing formula and human milk

Primary Outcome Measure Information:

Title

Length of Hospital Stay

Time Frame

One month

Secondary Outcome Measure Information:

Title

Time to Full Enteral Feeds

Time Frame

Three weeks

Title

Time on Total Parenteral Nutrition

Time Frame

Three weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Hours

Maximum Age & Unit of Time

48 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1) neonates born with gastroschisis 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study Exclusion Criteria: 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(<1500 grams)) 2) known major chromosomal abnormality

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Obinna O Adibe, MD, MHS

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23519369

Citation

Kohler JA Sr, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013 Aug;33(8):627-30. doi: 10.1038/jp.2013.27. Epub 2013 Mar 21.

Results Reference

background

PubMed Identifier

12483626

Citation

Sydorak RM, Nijagal A, Sbragia L, Hirose S, Tsao K, Phibbs RH, Schmitt SK, Lee H, Farmer DL, Harrison MR, Albanese CT. Gastroschisis: small hole, big cost. J Pediatr Surg. 2002 Dec;37(12):1669-72. doi: 10.1053/jpsu.2002.36689.

Results Reference

background

PubMed Identifier

24970346

Citation

Mastromarino P, Capobianco D, Campagna G, Laforgia N, Drimaco P, Dileone A, Baldassarre ME. Correlation between lactoferrin and beneficial microbiota in breast milk and infant's feces. Biometals. 2014 Oct;27(5):1077-86. doi: 10.1007/s10534-014-9762-3. Epub 2014 Jun 27.

Results Reference

background

PubMed Identifier

23752082

Citation

Gomez-Llorente C, Plaza-Diaz J, Aguilera M, Munoz-Quezada S, Bermudez-Brito M, Peso-Echarri P, Martinez-Silla R, Vasallo-Morillas MI, Campana-Martin L, Vives-Pinera I, Ballesta-Martinez MJ, Gil A. Three main factors define changes in fecal microbiota associated with feeding modality in infants. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):461-6. doi: 10.1097/MPG.0b013e31829d519a.

Results Reference

background

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Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

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