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CompletedNCT04841070NEUROPHONUpdated Nov 23, 2021

NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

An interventional study of Ages & Stages Questionnaires®, Third Edition (ASQ3) in Persistent Pulmonary Hypertension of the Newborn, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2021-11-23.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
1 Year to 5 Years
Sex
All
01

Study 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

02

Conditions studied

  • Persistent Pulmonary Hypertension of the Newborn
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 55 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Persistent pulmonary hypertension of the newborn.

    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

  • OtherAges & 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.

06

What researchers measure

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.

    Time frame: Between one and 5 years after hospitalization in resuscitation.

07

Study locations

1 site
  • CHU Toulouse
    Toulouse, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04841070
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Jul 25, 2021
Primary completion
Oct 29, 2021
Completion
Oct 29, 2021
Last update
Nov 23, 2021

Study contacts

Sophie BREINIG, MD
principal investigator · CHU Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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