NCT02738411

Brief Summary

The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5.6 years

First QC Date

April 11, 2016

Last Update Submit

November 14, 2025

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (1)

  • The presence/absence of a Th1 type immune orientation

    Immune orientation will be determined according to the following ratio determined by lymphocyte stimulation tests: INF-gamma/(INF-gamma+IL+4). The latter ratio varies between 0 and 0.5 with IL-4 \> INF-gamma (TH2 orientation) and between 0.5 and 1 when INF-gamma \> IL-4 (TH1 orientation).

    36 months

Secondary Outcomes (1)

  • Blood lymphocyte subset determination

    36 months

Other Outcomes (65)

  • Serum Immunoglobulin A level

    36 months

  • Serum Immunoglobulin G level

    36 months

  • Serum Immunoglobulin M level

    36 months

  • +62 more other outcomes

Study Arms (1)

The study population

The study population corresponds to infants born at less than 33 weeks of gestation.

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of premature babies born at \< 33 months gestation.

You may qualify if:

  • The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights
  • The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form
  • The patient must be affiliated with or beneficiary of a health insurance plan
  • Premature infants born at less than 33 weeks of gestation

You may not qualify if:

  • The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90.
  • It is not possible to correctly inform the parent (or legal guardian, if applicable)
  • A serious deformity or digestive malformation was diagnosed at birth
  • During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis)
  • A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Réseau GRANDIR EN LANGUEDOC-ROUSILLON

Saint-Gély-du-Fesc, 34980, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be drawn at 36 months for lymphocyte subpopulation characterization, stimulation tests and biobanking. Fecal samples at indicated time points will also be banked (bacterial rDNA will be extracted).

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Anne Filleron, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 14, 2016

Study Start

May 12, 2017

Primary Completion

November 28, 2022

Study Completion

December 30, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(3)