Normal intestinal development and disease in premature and full-term newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.