An observational study in Gastroschisis, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged Up to 3 Days. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Baylor College of Medicine · Observational
Among 18 studies in Gastroschisis with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Gastroschisis · United States.
Among the 18 studies in Gastroschisis with a site in United States, this one is one of 2 that started in 2017, is one of 3 observational ones, and was the 14th registered.
42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.
This study's enrollment of 27 is below the median of 53 across 14 observational studies indexed under Gastroschisis.
Browse Gastroschisis studies →5 of the 18 studies in Gastroschisis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 6 Gastroschisis studies recruiting now, 3 (50%) set no upper age limit and 3 (50%) stop at 75 or younger; 3 take children under 18; 0 take healthy volunteers.
This study: Up to 3 Days · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2017.
Median enrollment 24 across the 15 interventional studies, 30 across the 3 observational. Of the 11 that completed or were terminated, 4 (36%) have results posted.
None of the 18 has an industry lead sponsor. The 10 most frequent:
Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Baylor College of Medicine has 3 studies filed under Gastroschisis — fewer than ten, so there is no comparison to draw.
2 of the studies in Gastroschisis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03393832Baylor College of MedicineOral Care in Infants With Gastroschisis | 2026-12-30 |
| NCT06072976Seattle Children's HospitalThe Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies | 2027-06-09 |
Among the 18 studies in Gastroschisis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All infants admitted to the Texas Children's Hospital NICUs who have mother's milk available will receive oral care with mother's milk.
Infants will receive oral care with sterile water when mother's milk is not available.
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.
Time frame: 4 weeks
Days to start enteral feeds after primary surgical closure between the two cohorts
The first secondary objective is to compare the days to start enteral feeds after primary surgical closure between the two cohorts.
Time frame: 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 second secondary objective is to compare days to reach full enteral feeds of 140 cc/kg/day between the two study cohorts.
Time frame: The current average time to reach full enteral feeds is 105 days.
Length of stay between the two study cohorts
The third secondary objective is to compare length of stay between the two study cohorts.
Time frame: The current average length of stay is 70 days.
Salivary Gland Outcome: levels of salivary proteins between the two study cohorts
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.
Time frame: The average is 6 weeks.
Plan to share: No
Started Oct 2017 (actual). Primary completion is estimated for Dec 2026, 110 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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