Sham Feeding Post-operative Infants



Status:Recruiting
Conditions:Women's Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Reproductive
Healthy:No
Age Range:Any - 2
Updated:4/17/2018
Start Date:January 10, 2018
End Date:November 2020
Contact:Mark F Weems, MD
Email:mweems@uthsc.edu
Phone:901-448-5950

Use our guide to learn which trials are right for you!

Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants

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.

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.

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.
We found this trial at
1
site
Memphis, Tennessee 38103
Phone: 901-287-4878
?
mi
from
Memphis, TN
Click here to add this to my saved trials