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Trial record 20 of 31 for:    "Gastroschisis"

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
Sponsor:
Information provided by (Responsible Party):
Mark Weems, MD, Le Bonheur Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Newborn Morbidity Oral Aversion Gastroschisis Bowel Obstruction Short Bowel Syndrome Procedure: Sham Feeding Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: Sham Feeding Procedure: Sham Feeding
Sham feeding will be offered to participants.
Other Name: Observation




Primary Outcome Measures :
  1. Time to full feeds [ Time Frame: 1 year ]
    Time to full oral feeds after resolution of feeding contraindications


Secondary Outcome Measures :
  1. Growth [ Time Frame: 1 year ]
    Infant growth parameters

  2. Duration of breast feeding [ Time Frame: 1 year ]
    Duration of breast feeding or pumping of mother's milk

  3. Maternal satisfaction [ Time Frame: 1 year ]
    Maternal satisfaction survey after intervention



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mark F Weems, MD 901-448-5950 mweems@uthsc.edu
Contact: Alyssa Norris, RD 901-287-5948 mnorri23@uthsc.edu

Locations
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United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Mary Gaston, MSN    901-287-4878    mary.gaston@lebonheur.org   
Sub-Investigator: Margaret A Norris, RD         
Sub-Investigator: Huang Y Eunice, MD         
Sponsors and Collaborators
Le Bonheur Children's Hospital
Investigators
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Principal Investigator: Mark Weems, MD University of Tennessee Health Science Center

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Responsible Party: Mark Weems, MD, Assistant Professor of Pediatrics, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT03350022     History of Changes
Other Study ID Numbers: 17-05475-FB
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroschisis
Short Bowel Syndrome
Intestinal Obstruction
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical