NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

Not Applicable

Completed

• Conditions: Persistent Pulmonary Hypertension of the Newborn
• Interventions: Other: Ages & Stages Questionnaires®, Third Edition (ASQ3)

• Registration Number: NCT04841070
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology.

In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Study Start: 2021-07-25
• Primary Completion: 2021-10-29
• Study Completion: 2021-10-29
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• All parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal PAH in paediatric resuscitation

Exclusion Criteria

• Holders of parental authority who cannot answer the questionnaire because they do not speak French.
• Opposition of one of the two holders of parental authority
• Minor parental authority holders
• Holders of parental authority under safeguarding of justice, guardianship or guardianship
• Newborns with neonatal PAH with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease
• Newborns with neonatal PAH not treated with nitrogen monoxide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persistent pulmonary hypertension of the newborn.	Ages & Stages Questionnaires®, Third Edition (ASQ3)	Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.

Primary Outcome Measures

Name	Time	Method
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.	Between one and 5 years after hospitalization in resuscitation.	Parents will complete ASQ3. The investigators will consider neuro-psychomotor developmental disorders in children with pathological ASQ questionnaire on at least 2 items.

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France