NCT03950193

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

Same day

First QC Date

May 13, 2019

Last Update Submit

November 22, 2022

Conditions

Keywords

Parental presenceparental involvementparental stressdevelopment carepsychic development

Outcome Measures

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.

    Day 0

Study Arms (1)

premature child

Premature children evaluated during their 24 months follow up consultation

Other: Questionnaires to evaluate psychic development of the child

Interventions

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.

premature child

Eligibility Criteria

Age22 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Premature children

You may not qualify if:

  • \- child has a serious pathology (abnormal brain MRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

March 19, 2021

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations