What is the Future of Vulnerable New-borns

NCT ID: NCT04021654

Last Updated: 2024-09-19

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

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service), it means, newborns who are in these following risk categories:

* Birth before 33 weeks of amenorrhea
* Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age
* Perinatal anoxic-ischemia
* Other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
* A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. The data collect allow us to monitor these parameters and do a statistical study with them.

These information may be used to inform the parents about the future of the premature children cared at Pontoise. They also may be used to compare these children's future with the national data (EPIPAGE 2)

Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Children born in normal conditions.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Miler

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

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Centre Hospitalier René Dubos

Pontoise, , France

Site Status

Countries

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France

Other Identifiers

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CHRD0318

Identifier Type: -

Identifier Source: org_study_id

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