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Oral Care in Infants With Gastroschisis

NCT03393832 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2026-02-03

No results posted yet for this 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.

Conditions

  • Gastroschisis

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Amy B Hair, MD · Baylor College of Medicine

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-14
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393832 on ClinicalTrials.gov