Oral Care in Infants With Gastroschisis

Active, not recruiting

• Conditions: Gastroschisis

• Registration Number: NCT03393832
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Breast milk is recommended for most infants by the American Academy of Pediatrics as there are multiple benefits. However, some infants, such as extremely premature infants, are unable to receive enteral nutrition for a variety of clinical reasons. In order provide these infants with some of the benefits of mother's milk, a novel adjunctive therapy called oral care has been developed. Oral care consists of applying mother's breast milk to the buccal mucosa. Oral care has been studied in the premature infant population and been shown to improve both feeding tolerance and to provide immune protection. Although only studied in the premature population, many institutions including Texas Children's Hospital have adopted oral care as a standard of care for all infants as oral care poses minimal risk to the patient and has many potential benefits. Gastroschisis is a rare abdominal wall defect. Although the survival rate for infants with gastroschisis is high, there are significant morbidities related to feeding intolerance and infection. The investigators believe that this population of patients will also benefit from oral care.

The mechanism by which oral care works is not completely understood. It is theorized that oral care stimulates the oropharyngeal-lymphoid tissue in the buccal mucosa. Additional mechanisms include alteration of the intestinal microbiome. The intestinal microbiome is the millions of microorganisms that line the intestine. Normally, there is a mutually beneficial relationship. The intestinal microbiome is altered by many factors, including gestational age, antibiotic use, type of delivery, etc. Alterations in the microbiome can be detrimental and cause severe diseases such as necrotizing enterocolitis. Thus, far studies have shown that oral care alters the oral microbiome to include more healthy bacteria. The investigators believe that oral care with breast milk will be associated with a more diverse fecal microbiota. Finally, the investigators will evaluate a novel mechanism by which the investigators believe oral care is protective; via increased salivary gland secretion of certain proteins important for healing. In particular, saliva contains vascular endothelial growth factor, which is important for palatal wound healing and alimentary tract healing.

Study Timeline

• Study Start: 2017-10-14
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Infants with a primary diagnosis of gastroschisis

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome Outcome	4 weeks	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 Outcome Measures

Name	Time	Method
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.	The first secondary objective is to compare the days to start enteral feeds after primary surgical closure between the two cohorts.
Length of stay between the two study cohorts	The current average length of stay is 70 days.	The third secondary objective is to compare length of stay between the two study cohorts.
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.	The second secondary objective is to compare days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts.
Salivary Gland Outcome: levels of salivary proteins between the two study cohorts	The average is 6 weeks.	The final secondary objective is to compare levels of salivary proteins between the two study cohorts from birth to when infant achieves full enteral feeds of 140 cc/kg/day, using either ELISA or Luminex Mulitplex assays.

Trial Locations

Locations (1)

Texas Children's Hospital Fetal Center and Newborn Center; 🇺🇸 Houston, Texas, United States