Short Bowel Syndrome Clinical Trial
Official title:
Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants
Verified date | February 2020 |
Source | Le Bonheur Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Le Bonheur Children's Hospital |
United States,
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 |
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