NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

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

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Key information

Conditions

Persistent Pulmonary Hypertension of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Persistent Fetal Circulation Syndrome Respiratory Tract Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ages & Stages Questionnaires®, Third Edition (ASQ3)

Other

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 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: NEUROPHON

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 12, 2021
Registry last updated: Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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