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CompletedNCT03950193parentpartUpdated Nov 23, 2022

Prematurity and Parental Involvement in Child Development Care

An observational study in Premature Birth, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 22 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-11-23.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1
Ages
22 Years to 26 Years
Sex
All
01

Study summary

The aims of the study is to evaluate the association between presence and parental participation in perinatal care and psychic development of the child at 24 months

Read the detailed description

In France, as in developed countries, the premature birth rate has been rising over the past few years. Premature labor is a particularly stressful birth. It is recognized that the level of parental stress is greater at a premature birth compared to a term birth. The neuro-developmental consequences of premature birth are important. A possible association between prematurity and the onset of mental disorders such as hyperactivity, inattention, emotional problems, conduct disorders, autistic disorders and social difficulties has been shown. It has been shown that parental presence, holding and skin to skin during hospitalization would be beneficial for the child's motor development and psychological well-being by reducing the stress of the child.

02

Conditions studied

  • Premature Birth

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Keywords

  • Parental presence
  • parental involvement
  • parental stress
  • development care
  • psychic development
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 1 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Premature children

Eligibility criteria

inclusion criteria : child born very prematurely between 27 and 31 weeks gestational age + 6 days child taken in charge at the intensive care unit of Reims University Hospital for at least 3 weeks child aged 24 months (+/- 2 months) the holders of parental authority are more 18 years old the holders of parental authority know how to speak, read and write French the holders of parental authority agree to participate in the study

exclusion criteria :

  • child has a serious pathology (abnormal brain MRI)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • premature child

    Premature children evaluated during their 24 months follow up consultation

    Other: Questionnaires to evaluate psychic development of the child

Interventions

  • OtherQuestionnaires to evaluate psychic development of the child

    Child Behaviour Checklist. This test, completed by parents and with 52 questions, is designed to screen children at high risk for emotional problems, mood disorders, anxiety, pervasive developmental problems, attention deficit and hyperactivity, antonymic reactions (oppostion, provocation) and sleep problems.

06

What researchers measure

Primary outcomes

  1. Child Behavior Check List

    This test, completed by parents and with 52 questions, is designed to screen children at high risk for emotional problems, mood disorders, anxiety, pervasive developmental problems, attention deficit and hyperactivity, antonymic reactions (oppostion, provocation) and sleep problems.

    Time frame: Day 0

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Study locations

1 site
  • Damien JOLLY
    Reims, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03950193
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
May 15, 2019
Start date
Mar 19, 2021
Primary completion
Mar 19, 2021
Completion
Mar 19, 2021
Last update
Nov 23, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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