Study of Normal Intestinal Development and Disease in Premature and Term Neonates (NiiCE)

Boston Children's Hospital

Status: Not yet enrolling

Conditions: Intestinal Disease; Necrotizing Enterocolitis; NEC; Human Development

Study type: Observational

Funder types: Other

Identifiers

NCT06681129

IRB-P00033538

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Neonates

Description:

Any neonate or infant up to 2 years of age scheduled for an intestinal surgery or an esophogastroduodenoscopy or colonoscopy.