NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

NCT04841070 | Completed

• 1 other identifier: RC31/21/0186
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Persistent pulmonary hypertension of the newborn.

EXPERIMENTAL

Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn.

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

Interventions

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.

Persistent pulmonary hypertension of the newborn.

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Interventions

Glycation End Products, Advanced

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Toxins, Biological; Biological Factors

Study Officials

• Sophie BREINIG, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: July 25, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

FR (1)