Sham Feeding Post-operative Infants
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|ClinicalTrials.gov Identifier: NCT03350022|
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Newborn Morbidity Oral Aversion Gastroschisis Bowel Obstruction Short Bowel Syndrome||Procedure: Sham Feeding||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||315 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants|
|Actual Study Start Date :||January 10, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2020|
|Experimental: Sham Feeding||
Procedure: Sham Feeding
Sham feeding will be offered to participants.
Other Name: Observation
- Time to full feeds [ Time Frame: 1 year ]Time to full oral feeds after resolution of feeding contraindications
- Growth [ Time Frame: 1 year ]Infant growth parameters
- Duration of breast feeding [ Time Frame: 1 year ]Duration of breast feeding or pumping of mother's milk
- Maternal satisfaction [ Time Frame: 1 year ]Maternal satisfaction survey after intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350022
|Contact: Mark F Weems, MDemail@example.com|
|Contact: Alyssa Norris, RDfirstname.lastname@example.org|
|United States, Tennessee|
|Le Bonheur Children's Hospital||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Mary Gaston, MSN 901-287-4878 email@example.com|
|Sub-Investigator: Margaret A Norris, RD|
|Sub-Investigator: Huang Y Eunice, MD|
|Principal Investigator:||Mark Weems, MD||University of Tennessee Health Science Center|