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Sham Feeding Post-operative Infants

Primary Purpose

Newborn Morbidity, Oral Aversion, Gastroschisis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Feeding
Sponsored by
Le Bonheur Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Newborn Morbidity

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Le Bonheur Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sham Feeding

Arm Description

Outcomes

Primary Outcome Measures

Time to full feeds
Time to full oral feeds after resolution of feeding contraindications

Secondary Outcome Measures

Growth
Infant growth parameters
Duration of breast feeding
Duration of breast feeding or pumping of mother's milk
Maternal satisfaction
Maternal satisfaction survey after intervention

Full Information

First Posted
November 17, 2017
Last Updated
February 18, 2020
Sponsor
Le Bonheur Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03350022
Brief Title
Sham Feeding Post-operative Infants
Official Title
Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Le Bonheur Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Morbidity, Oral Aversion, Gastroschisis, Bowel Obstruction, Short Bowel Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Feeding
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sham Feeding
Other Intervention Name(s)
Observation
Intervention Description
Sham feeding will be offered to participants.
Primary Outcome Measure Information:
Title
Time to full feeds
Description
Time to full oral feeds after resolution of feeding contraindications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Growth
Description
Infant growth parameters
Time Frame
1 year
Title
Duration of breast feeding
Description
Duration of breast feeding or pumping of mother's milk
Time Frame
1 year
Title
Maternal satisfaction
Description
Maternal satisfaction survey after intervention
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Lack of consent or parental consent. Contraindication to sham feeding as determined by the responsible medical provider.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Weems, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sham Feeding Post-operative Infants

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