NCT06681129 Study of Normal Intestinal Development and Disease in Premature and Term Neonates
| NCT ID | NCT06681129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | NEC |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2031-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-17 with a primary completion date of 2031-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs between the two species. Further, prior research has demonstrated that some proteins and pathways that are critical in human development have no clear role in mice. This study aims to improve the overall understanding of critical aspects of intestinal development in humans. In addition, this study will investigate the impact of intestinal diseases that are found in the early stages of life such as necrotizing enterocolitis (NEC).
Eligibility 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.
Contact & Investigator
Amy O'Connell, MD, PhD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT06681129 clinical trial?
This trial is open to participants of all sexes, up to 2 Years, studying NEC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06681129 currently recruiting?
Yes, NCT06681129 is actively recruiting participants. Contact the research team at Amy.OConnell@childrens.harvard.edu for enrollment information.
Where is the NCT06681129 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06681129 clinical trial?
NCT06681129 is sponsored by Boston Children's Hospital. The principal investigator is Amy O'Connell, MD, PhD at Boston Children's Hospital. The trial plans to enroll 100 participants.