Anoxic-Ischemic EncephalopathySARNATUNNCT03744481
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
An observational study of Anoxic-Ischemic Encephalopathy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Anoxic-Ischemic Encephalopathy
- What is being tested?
- Questionaire
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2019to 2 Aug 2019
- Phase
- Observational
- 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 2 to 7 years
- All sexes
- Child
Study population: Full term children with perinatal asphyxia and with clinical signs of mild EAI without indication of therapeutic hypothermia
Who may be able to join
- Full-term children, gestational age> 36 weeks of amenorrhea
- Between the 1st of January 2012 and the 31st of December 2016
- Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon
- Perinatal asphyxia with clinical signs of encephalopathy
- Indication of therapeutic hypothermia not retained because EAI mild
- Where parents were informed and did not object to participation in the study
Who cannot join
- Dysmorphic syndrome
- Stroke
- Children transferred for other criteria (respiratory distress, heart failure ...)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation néonatale - Hôpital de la Croix Rousse
Lyon, 69317
About this study
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.
There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.
The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.
- Conditions
- Anoxic-Ischemic Encephalopathy
- Being tested
- Questionaire
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
Evaluation of psychomotor development in children with mild EAI without indication of therapeutic hypothermia.
Precise analysis of the type (motor, sensory, language, epilepsy) and the severity of sequelae by sending a questionnaire to parents.
Investigation of early, clinical and paraclinical prognostic factors of good or bad neurodevelopmental outcome.
Evaluation of the height-weight growth and the cranial perimeter
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of abnormalities
Abnormalities researched are : abnormal motor, sensory (auditory or visual), delayed psychomotor acquisition compared to the expected (norms), or epilepsy at 2 years.
These anomalies will be collected by sending a questionnaire to the parents.
Measured: maximum 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start19 May 2019
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744481
- Sponsor's protocol ID
- 69HCL18_0627
- Acronym
- SARNATUN
- Status last verified
- Oct 2019
- First submitted
- 14 Nov 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT03744481
- Acronym / sponsor ID
- SARNATUN / 69HCL18_0627
- Conditions
- Anoxic-Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 May 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 16 Nov 2018 (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.
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.
There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.
The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Full term children with perinatal asphyxia and with clinical signs of mild EAI without indication of therapeutic hypothermia
Key inclusion criteria (6 listed)
- Full-term children, gestational age> 36 weeks of amenorrhea
- Between the 1st of January 2012 and the 31st of December 2016
- Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon
- Perinatal asphyxia with clinical signs of encephalopathy
- Indication of therapeutic hypothermia not retained because EAI mild
Key exclusion criteria (3 listed)
- Dysmorphic syndrome
- Stroke
- Children transferred for other criteria (respiratory distress, heart failure ...)
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 |
|---|---|---|
| QuestionaireEvaluation of psychomotor development in children with mild EAI without indication of therapeutic hypothermia. Precise analysis of the type (motor, sensory, language, epilepsy) and the severity of sequelae by sending a questionnaire to parents. Investigation of early, clinical and paraclinical prognostic factors of good or bad neurodevelopmental outcome. Evaluation of the height-weight growth and the cranial perimeter | Other | – |
Primary outcome
Existence of abnormalities
Time frame: maximum 1 years
Abnormalities researched are : abnormal motor, sensory (auditory or visual), delayed psychomotor acquisition compared to the expected (norms), or epilepsy at 2 years. These anomalies will be collected by sending a questionnaire to the parents.
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 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Anoxic-Ischemic Encephalopathy
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
RecruitingPhase 2
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Hypoxia-Ischemia, Brain, Heart Arrest
Active, not recruiting
Implementation of Neuro Lung Protective Ventilation
Acute Brain Injury, Traumatic Brain Injury
Enrolling by invitationObservational study
Intranasal AAV9-PHP.eB Gene Therapy in Cerebral Palsy (CP) & Hypoxic Ischemic Encephalopathy (HIE)
Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anoxic-Ischemic Encephalopathy, run by Hospices Civils de Lyon 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 6 inclusion and 3 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 1 Nov 2019. 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?
Existence of abnormalities (time frame: maximum 1 years). 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 1 Nov 2019.