Persistent Pulmonary Hypertension of the NewbornNEUROPHONNCT04841070
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
A study testing Ages & Stages Questionnaires®, Third Edition (ASQ3) in people with Persistent Pulmonary Hypertension of the Newborn, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn
- What is being tested?
- Ages & Stages Questionnaires®, Third Edition (ASQ3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2021to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: NEURodevelopmental Outcome in Children Between One and Five Years 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
- Being tested
- Ages & Stages Questionnaires®, Third Edition (ASQ3)
- Medical subject headings
- Persistent Fetal Circulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ages & Stages Questionnaires®, Third Edition (ASQ3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between one and 5 years after hospitalization in resuscitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start25 Jul 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary Hypertension of the NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie BREINIG, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841070
- Sponsor's protocol ID
- RC31/21/0186
- Acronym
- NEUROPHON
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn
- ClinicalTrials.gov ID
- NCT04841070
- Acronym / sponsor ID
- NEUROPHON / RC31/21/0186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent pulmonary hypertension of the newborn. | Experimental | Other: Ages & Stages Questionnaires®, Third Edition (ASQ3)Children aged 1 to 5 years who have been hospitalized in pediatric resuscitation service for the treatment of persistent pulmonary hypertension of the newborn. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ages & 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. | Other | Persistent pulmonary hypertension of the newborn. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie BREINIG, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ages & Stages Questionnaires®, Third Edition (ASQ3) in people with Persistent Pulmonary Hypertension of the Newborn, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.