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Completed

NCT Number: NCT04021654

What is the Future of Vulnerable New-borns

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.

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Key information

Age range

1 hour–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier René Dubos

Pontoise, 95303, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection

Procedure

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

Primary outcomes

  1. The pregnancy issues rate

    Time frame: 2 years

    Measure the rate of issues that occur during the pregnancy.

  2. Delivrey issues rate

    Time frame: 2 years

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

  3. % of preterm children with a failure to thrive.

    Time frame: 2 years

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: DNNV

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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