Status:
COMPLETED
Sham Feeding Post-operative Infants
Lead Sponsor:
Le Bonheur Children's Hospital
Conditions:
Newborn Morbidity
Oral Aversion
Eligibility:
All Genders
Up to 2 years
Phase:
NA
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 fee...
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...
Eligibility Criteria
Inclusion
- 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
- Lack of consent or parental consent.
- Contraindication to sham feeding as determined by the responsible medical provider.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03350022
Start Date
January 10 2018
End Date
September 4 2019
Last Update
February 20 2020
Active Locations (1)
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1
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103