Back to resultsNEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn (NEUROPHON)
Primary Purpose
Persistent Pulmonary Hypertension of the Newborn
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ages & Stages Questionnaires®, Third Edition (ASQ3)
Sponsored by
About this trial
This is an interventional other trial for Persistent Pulmonary Hypertension of the Newborn
Eligibility Criteria
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
Sites / Locations
- CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Persistent pulmonary hypertension of the newborn.
Arm Description
Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.
Outcomes
Primary Outcome Measures
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04841070
First Posted
April 8, 2021
Last Updated
November 15, 2021
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04841070
Brief Title
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
Acronym
NEUROPHON
Official Title
NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pulmonary Hypertension of the Newborn
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persistent pulmonary hypertension of the newborn.
Arm Type
Experimental
Arm Description
Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.
Intervention Type
Other
Intervention Name(s)
Ages & Stages Questionnaires®, Third Edition (ASQ3)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.
Description
Parents will complete ASQ3. The investigators will consider neuro-psychomotor developmental disorders in children with pathological ASQ questionnaire on at least 2 items.
Time Frame
Between one and 5 years after hospitalization in resuscitation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie BREINIG, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
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