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Clinical Trials/NCT04841070
NCT04841070
Completed
Not Applicable

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

University Hospital, Toulouse1 site in 1 country55 target enrollmentJuly 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Persistent Pulmonary Hypertension of the Newborn
Sponsor
University Hospital, Toulouse
Enrollment
55
Locations
1
Primary Endpoint
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 25, 2021
End Date
October 29, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.

Time Frame: 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.

Study Sites (1)

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