NECNiiCENCT06681129
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
An observational study of NEC and Necrotizing Enterocolitis, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- NEC, Necrotizing Enterocolitis, Intestinal Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Neonates or infants that are admitted to the in-patient units for intestinal intervention.
Who may be able to join
- Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.
Who cannot join
- Children > 2 years of age.
- Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Amy O'Connell, MD
About this study
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
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).
- Conditions
- NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development
- Keywords
- NEC, Early Intestinal Development, Intestinal Intervention, Necrotizing Enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Any neonate or infant up to 2 years of age scheduled for an intestinal surgery or an esophogastroduodenoscopy or colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intestinal stem cells and mature epithelial cells
Small intestinal biopsy specimens will be collected either from discarded surgical biopsies collected for clinical reasons or from 1-2 additional small bunch biopsies (5mm) near the surgery site. The tissue will be used to 1.) generate organoids for longitudinal cell culture, 2.) analyze RNA or protein components by transcriptomic or cellular analyses or 3.) analyze histology. We do not have discrete planned outcomes because this is an investigational study and we are looking for new trends or differences.
Measured: At the time of surgery for another clinical problem.
Degree of Immune System Changes
We will collect a small 1 tsp amount of blood (5mL) and use this to analyze immune cell types or cytokines in the blood. These will include monocytes, T cell, B cells, and neutrophils for the cell types. Cytokines will include IL-1, IL-2, IL-3, IL-4, Il-5, IL-6, Il-8, IL10, IL-13, IL-22, IL-33, TNFa, IFNg, IFNa, MCP1, MIP1a.
Measured: Within 48 hours before or after the clinically-driven surgery.
Fraction of Stool Microbiome that has beneficial microbes
We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.
Measured: Within 48 hours before or after the surgery from which the biopsy is obtained.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start17 Mar 2025
- Primary completion1 Sep 2031 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NECStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy O'Connell, Boston Children's Hospital
- Investigators
- Amy O'Connell, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681129
- Sponsor's protocol ID
- IRB-P00033538
- Acronym
- NiiCE
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06681129
- Acronym / sponsor ID
- NiiCE / IRB-P00033538
- Conditions
- NEC, Necrotizing Enterocolitis, Intestinal Disease, Human Development
- Keywords
- NEC, Early Intestinal Development, Intestinal Intervention, Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | –Any neonate or infant up to 2 years of age scheduled for an intestinal surgery or an esophogastroduodenoscopy or colonoscopy. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates or infants that are admitted to the in-patient units for intestinal intervention.
Key inclusion criteria (1 listed)
- Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.
Key exclusion criteria (2 listed)
- Children > 2 years of age.
- Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of intestinal stem cells and mature epithelial cells
Time frame: At the time of surgery for another clinical problem.
Small intestinal biopsy specimens will be collected either from discarded surgical biopsies collected for clinical reasons or from 1-2 additional small bunch biopsies (5mm) near the surgery site. The tissue will be used to 1.) generate organoids for longitudinal cell culture, 2.) analyze RNA or protein components by transcriptomic or cellular analyses or 3.) analyze histology. We do not have discrete planned outcomes because this is an investigational study and we are looking for new trends or differences.
Degree of Immune System Changes
Time frame: Within 48 hours before or after the clinically-driven surgery.
We will collect a small 1 tsp amount of blood (5mL) and use this to analyze immune cell types or cytokines in the blood. These will include monocytes, T cell, B cells, and neutrophils for the cell types. Cytokines will include IL-1, IL-2, IL-3, IL-4, Il-5, IL-6, Il-8, IL10, IL-13, IL-22, IL-33, TNFa, IFNg, IFNa, MCP1, MIP1a.
Fraction of Stool Microbiome that has beneficial microbes
Time frame: Within 48 hours before or after the surgery from which the biopsy is obtained.
We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy O'Connell, MD, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NEC and Necrotizing Enterocolitis, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy O'Connell, MD, PhD (617-919-1807, Amy.OConnell@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intestinal stem cells and mature epithelial cells (time frame: At the time of surgery for another clinical problem.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.