Study of Normal Intestinal Development and Disease in Premature and Term Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development. Basic parameters: up to 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Primary outcome measures
- Number of intestinal stem cells and mature epithelial cells [Time frame: At the time of surgery for another clinical problem.]
- Degree of Immune System Changes [Time frame: Within 48 hours before or after the clinically-driven surgery.]
- Fraction of Stool Microbiome that has beneficial microbes [Time frame: Within 48 hours before or after the surgery from which the biopsy is obtained.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT06681129 · IRB-P00033538