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NCT03393832 · ClinicalTrials.gov registry record
Oral Care in Infants With Gastroschisis
A clinical trial of Gastroschisis, sponsored by Baylor College of Medicine.
- Active
- Registry status
- 27
- Enrollment target
- 1
- Study location
NCT03393832: Active study of Gastroschisis, sponsored by Baylor College of Medicine.
NCT03393832 is a study of Gastroschisis that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 27 participants, below the 90-participant average among 4 other Gastroschisis trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393832, a study of Gastroschisis, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance and protect against infection. Though only studied in premature infants, it is likely that other populations of patients can benefit form oral care as well. This is a prospective observational cohort study looking at infants with gastroschisis admitted to the Texas Children's Hospital Newborn Center NICU (level II and level IV) who receive oral care with mother's milk or sterile water when mother's milk is not available. The study is aimed to demonstrate the benefits of oral care with breast milk in infants with gastroschisis. Additionally, the investigators will evaluate how oral care with breast milk affects the intestinal bacterial environment and how oral care with breast milk affects the secretion of certain proteins from the salivary gland. Primary hypothesis: The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis. Secondary hypothesis: * Oral care with breast milk will decrease the days to start enteral feeds after primary surgical closure inpatients with gastroschisis. * Oral care with breast milk will decrease the days to reach full enteral feeds of 140 cc/kg/day in patients with gastroschisis. * Oral care with breast milk will decrease length of stay in patients with gastroschisis. * Oral care with breast milk will increase secretion of certain proteins, such as vascular endothelial growth factor, from the salivary gland.
Primary Outcome
The primary objective is to compare the magnitude of increase in intestinal microbiota alpha diversity over a four week period between infants who receive oral care with mother's milk and those receiving oral care with sterile water using a paired analysis.
Conditions Studied
Study Locations (1)
Texas
- Texas Children's Hospital Fetal Center and Newborn Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-10-14 |
| Est. Completion | 2026-12-30 |
What the registry record for NCT03393832 still lists
NCT03393832 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 90-participant average among 4 other Gastroschisis trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Gastroschisis appearing as the primary indexed condition, and to 0 interventions.
NCT03393832 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03393832 about?
NCT03393832 is a clinical study titled "Oral Care in Infants With Gastroschisis". Gastroschisis is a rare abdominal wall defect. Though survival rate is high, there are significant complications related to feeding intolerance and infections. Recently, oral care with breast milk has been studied in extremely premature infants and has been shown to improve both feeding tolerance an...
What is the current status of trial NCT03393832?
This trial is currently active not recruiting. The enrollment target is 27 participants. The study started on 2017-10-14. Estimated completion is 2026-12-30.
What conditions does trial NCT03393832 study?
This clinical trial studies the following conditions: Gastroschisis.
Who is sponsoring clinical trial NCT03393832?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03393832 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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