NEUROPHON: NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT04841070

Collaborator

(none)

Enrollment

Location

Arm

3.2

Actual Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Persistent Pulmonary Hypertension of the Newborn	Other: Ages & Stages Questionnaires®, Third Edition (ASQ3)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn

Actual Study Start Date :

Jul 25, 2021

Actual Primary Completion Date :

Oct 29, 2021

Actual Study Completion Date :

Oct 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Persistent pulmonary hypertension of the newborn. Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.	Other: Ages & Stages Questionnaires®, Third Edition (ASQ3) Investigators will propose to parents of children hospitalized for the treatment of persistent pulmonary hypertension of the newborn a hetero-evaluation via the validated ASQ questionnaire to analyze neuro-psychomotor development.

Arm

Intervention/Treatment

Experimental: Persistent pulmonary hypertension of the newborn.

Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.

Other: Ages & Stages Questionnaires®, Third Edition (ASQ3)

Investigators will propose to parents of children hospitalized for the treatment of persistent pulmonary hypertension of the newborn a hetero-evaluation via the validated ASQ questionnaire to analyze neuro-psychomotor development.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Toulouse	Toulouse		France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Sophie BREINIG, MD, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT04841070

Other Study ID Numbers:

RC31/21/0186

First Posted:

Apr 12, 2021

Last Update Posted:

Nov 23, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension, Pulmonary

Persistent Fetal Circulation Syndrome

Hypertension

Study Results

No Results Posted as of Nov 23, 2021