Normal intestinal development and disease in premature and full-term newborns
Study of Normal Intestinal Development and Disease in Premature and Term Neonates - a Pathway for the Study of Premature and Neonatal Intestinal Disorders Including the Roles of Nutrition, Microbes, and Cellular Physiology, and Diseases Including Necrotizing Enterocolitis
Boston Children's Hospital · NCT06681129
This project will collect intestinal tissue from newborns and infants up to age 2 who have GI surgery or biopsies to see how the human intestine develops and how conditions like NEC affect it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06681129 on ClinicalTrials.gov |
What this trial studies
Most prior work on early intestinal development has relied on mouse models, which differ in timing and some key pathways from humans. This observational project will collect surgical and endoscopic biopsy samples from premature and term neonates and infants (up to 2 years) treated at the study site. Samples will undergo histologic and molecular analyses to map normal developmental patterns and disease-related changes such as those seen in necrotizing enterocolitis. Researchers will compare findings between premature and full-term infants to identify human-specific pathways and potential targets for future therapies.
Who should consider this trial
Good fit: Neonates and infants up to 2 years old who are undergoing intestinal surgery or an EGD/colonoscopy with biopsy are the intended participants.
Not a fit: Children older than 2 years and infants who are not undergoing GI surgery or biopsy are not eligible and are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the findings could lead to earlier detection, better-targeted treatments, or preventive strategies for NEC and other infant intestinal disorders.
How similar studies have performed: Most previous research used mouse models, and while some human tissue studies have offered useful insights, systematic collection and analysis of neonatal human intestinal samples for NEC-related questions is relatively uncommon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy. Exclusion Criteria: * Children \> 2 years of age. * Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Amy O'Connell, MD, PhD — Boston Children's Hospital
- Study coordinator: Amy O'Connell, MD, PhD
- Email: Amy.OConnell@childrens.harvard.edu
- Phone: 617-919-1807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development, Early Intestinal Development, Intestinal Intervention