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Trial record 94 of 1486 for:    child psychiatry

Prematurity and Parental Involvement in Child Development Care (parentpart)

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ClinicalTrials.gov Identifier: NCT03950193
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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

Condition or disease Intervention/treatment
Premature Birth Other: Questionnaires to evaluate psychic development of the child

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association Between Presence and Parental Participation in Perinatal Care and Child Psychiatric Profile at 24 Months After Preterm Birth
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Group/Cohort Intervention/treatment
premature child
Premature children evaluated during their 24 months follow up consultation
Other: Questionnaires 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.




Primary Outcome Measures :
  1. Child Behavior Check List [ Time Frame: Day 0 ]
    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.



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Ages Eligible for Study:   22 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature children
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950193


Contacts
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Contact: Julien EUTROPE 03 26 78 31 76 ext 0033 jeutrope@chu-reims.fr

Locations
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France
Damien JOLLY Not yet recruiting
Reims, France
Contact: Julien EUTROPE    03 26 78 31 76 ext 0033    jeutrope@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03950193     History of Changes
Other Study ID Numbers: PO19055
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
Parental presence
parental involvement
parental stress
development care
psychic development

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications