- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021654
What is the Future of Vulnerable New-borns (DNNV)
Study Overview
Detailed 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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Pontoise, France, 95303
- Centre Hospitalier Rene Dubos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pregnancy issues rate
Time Frame: 2 years
|
Measure the rate of issues that occur during the pregnancy.
|
2 years
|
Delivrey issues rate
Time Frame: 2 years
|
Measurement of the rate of issues that occur during the delivery.
|
2 years
|
% of preterm children with a failure to thrive.
Time Frame: 2 years
|
Measurement of the % of children with a failure to thrive.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of diseases in the children family health history.
Time Frame: 2 years
|
Census of all diseases that may be in the children family health history
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caroline Miler, Centre Hospitalier Rene Dubos
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD0318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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