An interventional study of Sham Feeding in Newborn Morbidity, Oral Aversion and Gastroschisis, sponsored by Le Bonheur Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Le Bonheur Children's Hospital · Not applicable, Interventional, and Prevention
Among 18 studies in Gastroschisis with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Gastroschisis · United States.
Among the 18 studies in Gastroschisis with a site in United States, this one is the 3rd largest by enrollment of the 15 interventional ones, is one of 4 that started in 2018, is one of 12 with no phase, and was the 13th registered.
42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.
This study's enrollment of 102 is above the median of 44 across 26 interventional studies indexed under Gastroschisis.
Browse Gastroschisis studies →5 of the 18 studies in Gastroschisis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 6 Gastroschisis studies recruiting now, 3 (50%) set no upper age limit and 3 (50%) stop at 75 or younger; 3 take children under 18; 0 take healthy volunteers.
This study: Up to 2 Years · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2018.
Median enrollment 24 across the 15 interventional studies, 30 across the 3 observational. Of the 11 that completed or were terminated, 4 (36%) have results posted.
None of the 18 has an industry lead sponsor. The 10 most frequent:
Le Bonheur Children's Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Le Bonheur Children's Hospital has 1 study filed under Gastroschisis — fewer than ten, so there is no comparison to draw.
2 of the studies in Gastroschisis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03393832Baylor College of MedicineOral Care in Infants With Gastroschisis | 2026-12-30 |
| NCT06072976Seattle Children's HospitalThe Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies | 2027-06-09 |
Among the 18 studies in Gastroschisis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Sham Feeding
Sham feeding will be offered to participants.
Also known as: Observation
Time to full feeds
Time to full oral feeds after resolution of feeding contraindications
Time frame: 1 year
Growth
Infant growth parameters
Time frame: 1 year
Duration of breast feeding
Duration of breast feeding or pumping of mother's milk
Time frame: 1 year
Maternal satisfaction
Maternal satisfaction survey after intervention
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Sep 2019, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Le Bonheur Children's Hospital