Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03950193
Other study ID # PO19055
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2021
Est. completion date March 19, 2021

Study information

Verified date November 2022
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date March 19, 2021
Est. primary completion date March 19, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years to 26 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Active, not recruiting NCT03655639 - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT03337659 - A Cluster Randomized Controlled Trial of FICare at 18 Months N/A
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Completed NCT03251729 - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix Phase 4
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Completed NCT02913495 - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Phase 4
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Not yet recruiting NCT02880696 - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates N/A
Completed NCT02743572 - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants N/A
Completed NCT02661360 - Effects of Swaddling on Infants During Feeding N/A
Completed NCT02879799 - Family Integrated Care (FICare) in Level II NICUs N/A
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Terminated NCT00675753 - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families N/A
Completed NCT00271115 - Kangaroo Holding and Maternal Stress N/A