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NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn (NEUROPHON)

T

Toulouse University Hospital

Status

Completed

Conditions

Persistent Pulmonary Hypertension of the Newborn

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04841070
RC31/21/0186

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

Persistent pulmonary hypertension of the newborn.
Experimental group
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.
Treatment:
Other: Ages & Stages Questionnaires®, Third Edition (ASQ3)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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