CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 27 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03393832
NCT03393832N/AActive

Oral Care: An Important Adjunctive Therapy to Improve Feeding Tolerance in Infants With Gastroschisis

Baylor College of Medicine·observational·Posted Jan 9, 2018·Updated Feb 3, 2026

In Brief

An observational study for Gastroschisis. Active but no longer recruiting, targeting 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastroschisis
CountriesUnited States
Collaborators--

Timeline

N/AActive
2018201920202021202220232024202520262027
First PostedJan 9, 2018
Enrollment StartOct 14, 2017
Primary CompletionDec 30, 2026
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 8.5 years agoPrimary completion in 6 months