Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

NCT ID: NCT03869827

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Necrotizing enterocolitis is the most common gastroenterological emergency in neonatology. Its mortality is high, ranging from 15 to 30%. Prematurity is the main risk factor for necrotizing enterocolitis, as well as the very low birth weight (\<1500 g) associated with prematurity. Among the early neonatal complications of intrauterine growth restriction neonates, necrotizing enterocolitis is frequently reported in the literature. The situation of chronic hypoxia of these fetuses is at the origin of a vascular redistribution favoring the cerebral circulation to the detriment of the mesenteric vascularization, which could lead to the development of an necrotizing enterocolitis. However, data from the literature concerning this over-risk of necrotizing enterocolitis in the case of intrauterine growth restriction are discordant. The heterogeneity of the definitions used for the intrauterine growth restriction and diagnostic criteria for necrotizing enterocolitis from one study to another could explain these discrepancies. The investigator's hypothesis is that the risk of necrotizing enterocolitis is higher among newborns in intrauterine growth restriction compared to control children.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Necrotizing Enterocolitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IUGR

All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2016.

necrotizing enterocolitis

Intervention Type OTHER

Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced

Control

To each of these children with intrauterine growth restriction is matched a control child: the child without intrauterine growth restriction of the same gestational age whose date of birth is consecutive to that of the case.

necrotizing enterocolitis

Intervention Type OTHER

Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

necrotizing enterocolitis

Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
* with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2011 to 31 december 2016.


* All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
* without isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2011 to 31 december 2016.

Exclusion Criteria

* Infants born out of the hospital and secondarily hospitalized in our department
* unaccompanied pregnancies
* multiple pregnancies
* children with malformations or genetic abnormalities,
* medical termination of pregnancy
* fetal deaths in utero
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muriel Doret, ¨Prof.

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Muriel Doret, Prof.

Role: CONTACT

4 27 85 51 70 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Muriel Doret, Prof.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECUN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RIC-NEC Randomized Controlled Trial
NCT05279664 ACTIVE_NOT_RECRUITING PHASE2
Prediction of NEC With Urinary iFABP
NCT01805206 WITHDRAWN PHASE2