Sham Feeding Post-operative Infants

Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants

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.

Study Overview

• Status: Completed
• Conditions: Newborn Morbidity; Gastroschisis; Bowel Obstruction; Short Bowel Syndrome; Oral Aversion
• Intervention / Treatment: Procedure: Sham Feeding

Detailed Description

There is a lack of literature and research on which to base interventions that intend to preserve and develop oral and motor feeding skills in the post-operative patient population during the critical window of opportunity to establish proper oral skills. Due to the lack of positive oral feeding stimuli (i.e. prolonged airway management, nasogastric tubes, and airway and upper GI suctioning), these patients are at risk to develop oral aversions that may negatively impact long-term outcomes.

Parents in the neonatal intensive care unit (NICU) report feelings of stress and loss of control associated with medical interventions. When normal oral feeding is contraindicated, there may be impairment of parent-child bonding and mothers may be less dedicated to providing milk for the infant. Impaired bonding has been shown to affect the parent-child relationship and the child's development long after discharge.

Sham feeding has been shown to be safe and shorten time to oral feeding in infants with esophageal atresia with delayed esophageal repair. Anecdotal evidence from Le Bonheur suggests that sham feeding in post-operative gastroschisis patients improves parental satisfaction and engagement.

There is no literature to describe the use of sham feeding in neonates other than those with esophageal atresia. Anecdotal reports from our institution and others institutions suggests that it increases parental engagement and improves parental satisfaction among patients with other bowel pathology.

This is a cohort study with historical controls within a single level IV NICU. Participants will be offered sham feeding by breast or bottle and observed.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Mothers of enrolled neonates

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham Feeding	Procedure: Sham Feeding; Sham feeding will be offered to participants.; Other Names: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to full feeds	Time to full oral feeds after resolution of feeding contraindications	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Infant growth parameters	1 year
Duration of breast feeding	Duration of breast feeding or pumping of mother's milk	1 year
Maternal satisfaction	Maternal satisfaction survey after intervention	1 year

Collaborators and Investigators

• Sponsor: Le Bonheur Children's Hospital
• Investigators: Principal Investigator: Mark Weems, MD, University of Tennessee Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): September 4, 2019
• Study Completion (Actual): September 4, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Malabsorption Syndromes; Musculoskeletal Abnormalities; Hernia; Gastroschisis; Intestinal Obstruction; Short Bowel Syndrome
• Other Study ID Numbers: 17-05475-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No