Oral Care in Infants With Gastroschisis

Running, not enrolling

Conditions studied: Gastroschisis

In brief

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.

Key facts

Study ID

NCT03393832

Run by

Baylor College of Medicine

People needed

27

Starts

2017-10-14

Expected to finish

2026-12-30

Last updated by the study team

2026-02-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants with a primary diagnosis of gastroschisis

You may not qualify if…

• Gestational age less than 30 weeks
• Birth weight less than 1,000 g
• Other major congenital anomalies or clinically significant heart disease
• First dose of oral care greater than 72 hours after birth
• Early transfer to another institution

Where it is running

• Texas Children's Hospital Fetal Center and Newborn Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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