NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

Persistent Pulmonary Hypertension of the Newborn Clinical Trial

— NEUROPHON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841070
• Other study ID #: RC31/21/0186
• Status: Completed
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of the Newborn

Intervention

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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between one and 5 years after hospitalization in resuscitation.