Oral Care in Infants With Gastroschisis

NCT03393832 | Active Not Recruiting

• 1 other identifier: H41227
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral care; Oropharyngeal mother's milk

Outcome Measures

Primary Outcomes (1)

• Microbiome 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.

  4 weeks

Secondary Outcomes (4)

• Days to start enteral feeds after primary surgical closure between the two cohorts

  The current average time to start feeds after surgical closure is 15 days.

• Days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts

  The current average time to reach full enteral feeds is 105 days.

• Length of stay between the two study cohorts

  The current average length of stay is 70 days.

• Salivary Gland Outcome: levels of salivary proteins between the two study cohorts

  The average is 6 weeks.

Study Arms (2)

Oral Care with Mother's Milk

All infants admitted to the Texas Children's Hospital NICUs who have mother's milk available will receive oral care with mother's milk.

Oral Care with Sterile Water

Infants will receive oral care with sterile water when mother's milk is not available.

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with a diagnosis of gastroschisis are identified either prenatally through the Texas Children's Hospital Fetal Center or upon admission to the Texas Children's Hospital Neonatal Intensive Care Unit (NICU).

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital Fetal Center and Newborn Center

Houston, Texas, 770230, United States

Location

Related Publications (36)

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Biospecimen

Retention: SAMPLES WITH DNA

Stools will be collected daily for 1st week of life then weekly for 3 weeks to study the intestinal microbiome and relative abundance of various bacteria. Oral care samples (mother's own milk) will be collected at time of stool collection to characterize/compare the abundance of bacteria in the oral care vs stool samples. Saliva will be collected to identify/quantify salivary gland proteins at these times: baseline sample following study enrollment (0-72 hours), before surgical closure of gastroschisis, daily from DOL 10 to when infant reaches full enteral feeds (140 cc/kg/day), and one after infant reaches full enteral feeds. Collected samples will be stored in the Neonatal Nutrition Research Biorepository.

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy B Hair, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: October 14, 2017
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)