Sham Feeding Post-operative Infants

NCT03350022 | Completed

• 1 other identifier: 17-05475-FB
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.

Conditions

Newborn Morbidity; Oral Aversion; Gastroschisis; Bowel Obstruction; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to full feeds

  Time to full oral feeds after resolution of feeding contraindications

  1 year

Secondary Outcomes (3)

• Growth

  1 year

• Duration of breast feeding

  1 year

• Maternal satisfaction

  1 year

Study Arms (1)

Sham Feeding

EXPERIMENTAL

Procedure: Sham Feeding

Interventions

Sham Feeding PROCEDURE

Sham feeding will be offered to participants.

Also known as: Observation

Sham Feeding

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates at least 34 weeks post-menstrual age who have a history of gastrointestinal surgery, require no respiratory support more than 2 lpm by nasal cannula, and have an anticipated prolonged course with contraindication to normal oral or enteral feeding. They must have a diagnosis of gastroschisis awaiting return of bowel function, bowel atresia or other obstruction with anticipated feeding contraindication longer than 30 days, or short bowel syndrome intolerant of full intermittent oral feeding.
• Mothers of enrolled neonates

You may not qualify if:

• Lack of consent or parental consent.
• Contraindication to sham feeding as determined by the responsible medical provider.

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Gastroschisis; Intestinal Obstruction; Short Bowel Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mark Weems, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: January 10, 2018
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)