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NCT04021654 Clinical Trial

What is the Future of Vulnerable New-borns

Preterm Birth Clinical Trial

— DNNV  

Official title:
What is the Future of Vulnerable New-borns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04021654
Other study ID # CHRD0318
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2020

Study information
Verified date February 2020
Source Centre Hospitalier René Dubos
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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)

Recruitment information / eligibility
Status Completed
Enrollment 257
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Centre Hospitalier René Dubos Pontoise

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The pregnancy issues rate Measure the rate of issues that occur during the pregnancy. 2 years
Primary Delivrey issues rate Measurement of the rate of issues that occur during the delivery. 2 years
Primary % of preterm children with a failure to thrive. Measurement of the % of children with a failure to thrive. 2 years
Secondary Number of diseases in the children family health history. Census of all diseases that may be in the children family health history 2 years
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