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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

Tracking Information
First Submitted Date May 13, 2019
First Posted Date May 15, 2019
Last Update Posted Date May 15, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prematurity and Parental Involvement in Child Development Care
Official Title Association Between Presence and Parental Participation in Perinatal Care and Child Psychiatric Profile at 24 Months After Preterm Birth
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premature children
Condition Premature Birth
Intervention 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.
Study Groups/Cohorts premature child
Premature children evaluated during their 24 months follow up consultation
Intervention: Other: Questionnaires to evaluate psychic development of the child
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 14, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
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)

Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 26 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Julien EUTROPE 03 26 78 31 76 ext 0033 jeutrope@chu-reims.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03950193
Other Study ID Numbers PO19055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date May 2019