Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03350022
Other study ID # 17-05475-FB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date September 4, 2019

Study information

Verified date February 2020
Source Le Bonheur Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 4, 2019
Est. primary completion date September 4, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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 Design


Intervention

Procedure:
Sham Feeding
Sham feeding will be offered to participants.

Locations

Country Name City State
United States Le Bonheur Children's Hospital Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to full feeds Time to full oral feeds after resolution of feeding contraindications 1 year
Secondary Growth Infant growth parameters 1 year
Secondary Duration of breast feeding Duration of breast feeding or pumping of mother's milk 1 year
Secondary Maternal satisfaction Maternal satisfaction survey after intervention 1 year
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05635747 - A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
Completed NCT01891279 - Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition? N/A
Completed NCT00930644 - Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) Phase 3
Completed NCT01696656 - Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency N/A
Completed NCT00910104 - Cholestasis Reversal: Efficacy of IV Fish Oil Phase 2/Phase 3
Completed NCT04981262 - Improved Quality of Life in Children With Intestinal Failure N/A
Completed NCT01930539 - Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp N/A
Recruiting NCT05023382 - A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Recruiting NCT04733066 - Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Terminated NCT00742157 - Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) Phase 4
Completed NCT04743960 - Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition N/A
Completed NCT03690206 - Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) Phase 3
Terminated NCT02266849 - Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study Phase 3
Completed NCT01306838 - Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy Early Phase 1
Completed NCT01380366 - rHGH and Intestinal Permeability in Intestinal Failure Phase 4
Completed NCT00248573 - Mechanisms of Adaptation in Human Short Bowel Syndrome Phase 1/Phase 2
Withdrawn NCT03371862 - Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS) Phase 2
Completed NCT04474743 - Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
Completed NCT00067860 - Diet/Growth Factor Mechanisms of Gut Adaptation Phase 2
Terminated NCT04046328 - Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome Phase 2