NCT04021654

Brief Summary

The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

July 11, 2019

Last Update Submit

September 3, 2024

Conditions

Preterm Birth

Keywords

Preterm birth; growth; neonatology; Pregnancy; Delivery

Outcome Measures

Primary Outcomes (3)

  • The pregnancy issues rate

    Measure the rate of issues that occur during the pregnancy.

    2 years

  • Delivrey issues rate

    Measurement of the rate of issues that occur during the delivery.

    2 years

  • % of preterm children with a failure to thrive.

    Measurement of the % of children with a failure to thrive.

    2 years

Secondary Outcomes (1)

  • Number of diseases in the children family health history.

    2 years

Interventions

Data collectionPROCEDURE

Data collection of growth, neuromotor, sensorial, behavioral, and cognitive development.

Eligibility Criteria

Age1 Hour - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm bith children

You may qualify if:

  • Birth before 33 weeks of amenorrhea
  • Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age.
  • Perinatal anoxic-ischemia
  • Other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.

You may not qualify if:

  • Children born in normal conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier René Dubos

Pontoise, 95303, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Caroline Miler

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 16, 2019

Study Start

September 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 19, 2024

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)