Sham Feeding Post-operative Infants

Completed · Not applicable · Has a placebo group

Conditions studied: Newborn Morbidity, Oral Aversion, Gastroschisis, Bowel Obstruction, Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT03350022

Run by

Le Bonheur Children's Hospital

People needed

102

Starts

2018-01-10

Expected to finish

2019-09-04

Last updated by the study team

2020-02-20

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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