Ischemic-Hypoxic EncephalopathyLyTONEPALNCT02676063
Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment
An observational study of Ischemic-Hypoxic Encephalopathy, run by University Hospital, Grenoble at 22 sites in France.
Trial summary
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic-Hypoxic Encephalopathy
- How many people
- 800 participants
- Where
- 22 sitesFrance
- Study dates
- Sep 2015to Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be performed on all moderate or severe cases of hypoxic ischemic encephalopathyhie, occurring between 34 and 42 completed weeks gestation in newborns admitted to a neonatal intensive care unit of the participating French regions. Children will be followed-up until the age of 3 years.
Who may be able to join
- Infants born at a gestational age of 34 weeks or more;
- Presenting early neurological distress with clinical signs of moderate to severe HIE at a standardized neurologic examination performed by a senior examiner:
- Moderate HIE: lethargy, hyper-reflexia, miosis, bradycardia, seizures, hypotonia with weak suck and Moro reflex
- Severe HIE: stupor, flaccidity, small to mid-position pupils that react poorly to light, reduced stretch reflexes, hypothermia or no Moro reflex
- With criteria for asphyxia:
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood sampled in the first hour after birth.
Show all 12Show fewer
- If, during this interval, the pH is between 7.01 and 7.15, base deficit is between 10 and 15.9 mmol per liter, or blood gas is not available, additional criteria will be required. These include:
- an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)
- or an abrupt change in fetal heart rate (FHR), defined as a persistent abnormal FHE after a period of normal tracing: bradycardia or prolonged deceleration, persistent variable decelerations, persistent late decelerations, and reduced heart variability
- or either a 10-minute Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes.
- Written parental informed consent
- Covered by the French social security
Who cannot join
- Congenital malformations
- Chromosomal disorders
- Congenital neuromuscular disorders
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Chu Amiens
Amiens, 80000
Chu Besancon
Besançon, 25000
Chu Bordeaux
Bordeaux, 33000
Chu Brest
Brest, 29200
CHU CAEN
Caen, 14000
CHU Clermond-Ferrand
Clermont-Ferrand, 63000
Chi Creteil
Créteil, 94000
Chu Dijon
Dijon, 21000
CHU FORT de France
Fort de France, 97200
Chu Grenoble
Grenoble, 38000
Chru Lille
Lille, 59000
Chu Limoges
Limoges, 87000
Chu Marseille
Marseille, 13000
CHU Montpellier
Montpellier, 34000
Chu La Miletrie
Poitiers, 86000
Chu Reims
Reims, 51100
Chu Rouen
Rouen, 76000
CHU St Denis
Saint-Denis de La Réunion, 97400
CHU St Pierre
Saint-Pierre, 97410
Chu Strasbourg
Strasbourg, 67000
Chu Toulouse
Toulouse, 31000
Chu Tours
Tours, 37000
About this study
Official title: Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE.
Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list:
- Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer
- Laboratory investigations: pH, lactates and new biological markers as detailed below
- Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI
Read the detailed description
Hypoxic-ischemic encephalopathy (HIE) is a rare neonatal condition affecting about 1‰ births and with a high rate of death and severe neurological disability despite significant improvement of the management of this illness in the last ten years. During the first hours and days of life, different examinations are made by neonatologists to guide decisions about the management of HIE and to provide information to families. Nevertheless, better knowledge about the early and late predictive factors of long-term severe and moderate neurodevelopmental outcomes is badly needed.
This study is a prospective national observational population-based study involving all level III intensive care units in France.
This population-based cohort study will be performed including all moderate or severe cases of HIE, occurring between 34 and 42 completed weeks gestation in newborns admitted to a neonatal intensive care unit of the participating French regions. Children will be followed-up until the age of 3 years.
Participating centers will be invited to adhere to current HIE management guidelines and/or clinical investigations considered optimal to date, to ensure standardize clinical practice. The study will ensure high quality data collection.
About indications, timing and characteristics of treatments and investigations will be elaborated by the scientific committee during the preparation stage of the cohort study. This professional advice will have the double advantage of enabling us to record more homogeneous and high-quality data, and to standardize and improve clinical management and investigations among newborns with HIE.
Within this main study, an ancillary study will be performed by 21 centers to address the first secondary objective (predictive value of very early - first 6 hours of life - neurological examination and biological investigations, including specific new biomarkers such as Interleukin-6, Metalloproteinase-9, TIMP-1, Albumin modified by hypoxia, troponin I, acylcarnitins and amino acids).
- Conditions
- Ischemic-Hypoxic Encephalopathy
- Keywords
- predictive factors, neurodevelopmental disabilities
- 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.
| Study group | Role | What they receive |
|---|---|---|
| neonatal Hypoxic Ischemic encephalopathy | moderate or severe HIE among term and late preterm newborn |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is a combined criterion : death, neurodevelopmental disabilities in survivors
A combined criterion which includes:
- Death between birth and 3 years of age
- Neurodevelopmental disabilities in survivors, defined as :
- Severe disabilities
- Intellectual impairment with a mental score >2SD below the mean or <70 (ASQ)
- Or Cerebral palsy with a Gross Motor Function level of 3-5 according to the GMFCS
- Or bilateral blindness (vision <20/200 acuity)
- Or deafness requiring amplification (>60dB)and/
- Or a persistent disorder defined as recurrent seizures after discharge from neonatal intensive care requiring anti-convulsion therapy at the examination time point
- Moderate disabilities
- Intellectual impairment with a mental score >1SD below the mean or 70 to 84 (ASQ)
- Cerebral palsy with a Gross Motor Function level of 1 or 2 according to the GMFCS
- Or hearing impairment requiring no amplification
Measured: between birth and 3 years of age
Secondary outcomes (4)
First secondary objective : The relevance of specific new biomarkers : Protein levels (IL-6, MMP-9, TIMP-1, Albumine modified by hypoxia, troponine I), acylcarnitins and amino acids.
The biologist will evaluate the relevance of specific new biomarkers :
- Protein levels (IL-6, MMP-9, TIMP-1, Albumine modified by hypoxia, troponine I) unites will be determined using an ELISA
- the measurement of acylcarnitins and amino acids by tandem liquid phase chromatography coupled with mass spectroscopy.
The analyses will be blinded and centralized to Reims University laboratory
Measured: before H6 and at 3 days
Second secondary objective: the predictive value of clinical investigations during the first weeks of life and treatments.
To analyze the predictive value of clinical investigations during the first weeks of life and treatments, including cooling:
- for normal outcomes (absence of death, any disability, any epilepsy or any need for physiotherapy, orthophonist or psychologist or other measures of reeducation), moderate or severe neurodevelopmental disabilities, and death
- At 18 months and 3 years of age
- In this part, we will assess the ability of a normal developmental assessment at 18 months to predict survival free of disability or retardation at 3 years. This information will be useful in the future to define different strategies of follow up according to the assessment at 18 months of age.
Measured: first week, At 18 months and 3 years of age
Third secondary objective : Number and percentage of participants with cooling.
The third secondary objective is analyzed thanks to :
- number of patients with method of cooling : Criticool, tecotherm, craft, other
- duration of cooling in hours
- number of severe or modere HIE according to the Sarnat classification
- time to initiate cooling in minutes
Measured: birth
Fourth secondary objective : Number and percentage of various obstetrical conditions leading to the worse outcomes
Number and percentage of :
- Maternal pyrexia,
- a persistent occipito-posterior position,
- an acute intrapartum event (hemorrhage, maternal convulsions, rupture of uterus, snapped cord, and birth of baby before arrival at obstetric facility),
- an instrumental vaginal delivery
- an emergency caesarean section
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ischemic-Hypoxic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry DEBILLON, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676063
- Sponsor's protocol ID
- DCIC1416
- Acronym
- LyTONEPAL
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647.
PubMed 22926849Use and abuse of the Apgar score. Committee on Fetus and Newborn, American Academy of Pediatrics, and Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Pediatrics. 1996 Jul;98(1):141-2.
PubMed 8668389Fenichel GM. Hypoxic-ischemic encephalopathy in the newborn. Arch Neurol. 1983 May;40(5):261-6. doi: 10.1001/archneur.1983.04050050029002.
PubMed 6405725Levene ML, Kornberg J, Williams TH. The incidence and severity of post-asphyxial encephalopathy in full-term infants. Early Hum Dev. 1985 May;11(1):21-6. doi: 10.1016/0378-3782(85)90115-x.
PubMed 4006822Debillon T, Vilotitch A, Guellec I, Marret S, Baud O, Chevallier M, Sentilhes L, Kayem G, Pierrat V, Ego A. Neonatal encephalopathy and 3 year outcomes: a French population-based cohort. Pediatr Res. 2026 Apr 30. doi: 10.1038/s41390-026-05022-3. Online ahead of print.
PubMed 42062519Binet L, Debillon T, Beck J, Vilotitch A, Guellec I, Ego A, Chevallier M; LYTONEPAL research group. Effect of gestational age on cerebral lesions in neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2024 Aug 16;109(5):562-568. doi: 10.1136/archdischild-2023-326131.
PubMed 38418209Guellec I, Ancel PY, Beck J, Loron G, Chevallier M, Pierrat V, Kayem G, Vilotitch A, Baud O, Ego A, Debillon T. Glycemia and Neonatal Encephalopathy: Outcomes in the LyTONEPAL (Long-Term Outcome of Neonatal Hypoxic EncePhALopathy in the Era of Neuroprotective Treatment With Hypothermia) Cohort. J Pediatr. 2023 Jun;257:113350. doi: 10.1016/j.jpeds.2023.02.003. Epub 2023 Feb 23.
PubMed 36828343Debillon T, Sentilhes L, Kayem G, Chevallier M, Zeitlin J, Baud O, Vilotitch A, Pierrat V, Guellec I, Ancel PY, Bednarek N, Ego A. Risk factors for unfavorable outcome at discharge of newborns with hypoxic-ischemic encephalopathy in the era of hypothermia. Pediatr Res. 2023 Jun;93(7):1975-1982. doi: 10.1038/s41390-022-02352-w. Epub 2022 Oct 22.
PubMed 36272997Beck J, Debillon T, Guellec I, Vilotitch A, Loron G, Bednarek N, Ancel PY, Pierrat V, Ego A. Healthcare organizational factors associated with delayed therapeutic hypothermia in neonatal hypoxic-ischemic encephalopathy: the LyTONEPAL cohort. Eur J Pediatr. 2023 Jan;182(1):181-190. doi: 10.1007/s00431-022-04666-7. Epub 2022 Oct 21.
PubMed 36269426Beck J, Bednarek N, Pierrat V, Vilotitch A, Loron G, Alison M, Guellec I, Hertz-Pannier L, de Launay C, Ego A, Vo-Van P, Ancel PY, Debillon T. Cerebral injuries in neonatal encephalopathy treated with hypothermia: French LyTONEPAL cohort. Pediatr Res. 2022 Sep;92(3):880-887. doi: 10.1038/s41390-021-01846-3. Epub 2021 Nov 20.
PubMed 34802036Debillon T, Bednarek N, Ego A; LyTONEPAL Writing Group. LyTONEPAL: long term outcome of neonatal hypoxic encephalopathy in the era of neuroprotective treatment with hypothermia: a French population-based cohort. BMC Pediatr. 2018 Aug 1;18(1):255. doi: 10.1186/s12887-018-1232-6.
PubMed 30068301
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia
- ClinicalTrials.gov ID
- NCT02676063
- Acronym / sponsor ID
- LyTONEPAL / DCIC1416
- Conditions
- Ischemic-Hypoxic Encephalopathy
- Keywords
- predictive factors, neurodevelopmental disabilities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- 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.
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE.
Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list:
- Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer
- Laboratory investigations: pH, lactates and new biological markers as detailed below
- Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI
Detailed description
Hypoxic-ischemic encephalopathy (HIE) is a rare neonatal condition affecting about 1‰ births and with a high rate of death and severe neurological disability despite significant improvement of the management of this illness in the last ten years. During the first hours and days of life, different examinations are made by neonatologists to guide decisions about the management of HIE and to provide information to families. Nevertheless, better knowledge about the early and late predictive factors of long-term severe and moderate neurodevelopmental outcomes is badly needed.
This study is a prospective national observational population-based study involving all level III intensive care units in France.
This population-based cohort study will be performed including all moderate or severe cases of HIE, occurring between 34 and 42 completed weeks gestation in newborns admitted to a neonatal intensive care unit of the participating French regions. Children will be followed-up until the age of 3 years.
Participating centers will be invited to adhere to current HIE management guidelines and/or clinical investigations considered optimal to date, to ensure standardize clinical practice. The study will ensure high quality data collection.
About indications, timing and characteristics of treatments and investigations will be elaborated by the scientific committee during the preparation stage of the cohort study. This professional advice will have the double advantage of enabling us to record more homogeneous and high-quality data, and to standardize and improve clinical management and investigations among newborns with HIE.
Within this main study, an ancillary study will be performed by 21 centers to address the first secondary objective (predictive value of very early - first 6 hours of life - neurological examination and biological investigations, including specific new biomarkers such as Interleukin-6, Metalloproteinase-9, TIMP-1, Albumin modified by hypoxia, troponin I, acylcarnitins and amino acids).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonatal Hypoxic Ischemic encephalopathy | – | –moderate or severe HIE among term and late preterm newborn |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be performed on all moderate or severe cases of hypoxic ischemic encephalopathyhie, occurring between 34 and 42 completed weeks gestation in newborns admitted to a neonatal intensive care unit of the participating French regions. Children will be followed-up until the age of 3 years.
Key inclusion criteria (12 listed)
- Infants born at a gestational age of 34 weeks or more;
- Presenting early neurological distress with clinical signs of moderate to severe HIE at a standardized neurologic examination performed by a senior examiner:
- With criteria for asphyxia:
- Written parental informed consent
- Covered by the French social security
Key exclusion criteria (3 listed)
- Congenital malformations
- Chromosomal disorders
- Congenital neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is a combined criterion : death, neurodevelopmental disabilities in survivors
Time frame: between birth and 3 years of age
A combined criterion which includes: * Death between birth and 3 years of age * Neurodevelopmental disabilities in survivors, defined as : o Severe disabilities * Intellectual impairment with a mental score >2SD below the mean or <70 (ASQ) * Or Cerebral palsy with a Gross Motor Function level of 3-5 according to the GMFCS * Or bilateral blindness (vision <20/200 acuity) * Or deafness requiring amplification (>60dB)and/ * Or a persistent disorder defined as recurrent seizures after discharge from neonatal intensive care requiring anti-convulsion therapy at the examination time point o Moderate disabilities * Intellectual impairment with a mental score >1SD below the mean or 70 to 84 (ASQ) * Cerebral palsy with a Gross Motor Function level of 1 or 2 according to the GMFCS * Or hearing impairment requiring no amplification
4 secondary outcomes
First secondary objective : The relevance of specific new biomarkers : Protein levels (IL-6, MMP-9, TIMP-1, Albumine modified by hypoxia, troponine I), acylcarnitins and amino acids.
Time frame: before H6 and at 3 days
Second secondary objective: the predictive value of clinical investigations during the first weeks of life and treatments.
Time frame: first week, At 18 months and 3 years of age
Third secondary objective : Number and percentage of participants with cooling.
Time frame: birth
Fourth secondary objective : Number and percentage of various obstetrical conditions leading to the worse outcomes
Time frame: birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 22926849Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647.
- Background: PubMed 8668389Use and abuse of the Apgar score. Committee on Fetus and Newborn, American Academy of Pediatrics, and Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Pediatrics. 1996 Jul;98(1):141-2.
- Background: PubMed 6405725Fenichel GM. Hypoxic-ischemic encephalopathy in the newborn. Arch Neurol. 1983 May;40(5):261-6. doi: 10.1001/archneur.1983.04050050029002.
- Background: PubMed 4006822Levene ML, Kornberg J, Williams TH. The incidence and severity of post-asphyxial encephalopathy in full-term infants. Early Hum Dev. 1985 May;11(1):21-6. doi: 10.1016/0378-3782(85)90115-x.
- Derived from this study: PubMed 42062519Debillon T, Vilotitch A, Guellec I, Marret S, Baud O, Chevallier M, Sentilhes L, Kayem G, Pierrat V, Ego A. Neonatal encephalopathy and 3 year outcomes: a French population-based cohort. Pediatr Res. 2026 Apr 30. doi: 10.1038/s41390-026-05022-3. Online ahead of print.
- Derived from this study: PubMed 38418209Binet L, Debillon T, Beck J, Vilotitch A, Guellec I, Ego A, Chevallier M; LYTONEPAL research group. Effect of gestational age on cerebral lesions in neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2024 Aug 16;109(5):562-568. doi: 10.1136/archdischild-2023-326131.
- Derived from this study: PubMed 36828343Guellec I, Ancel PY, Beck J, Loron G, Chevallier M, Pierrat V, Kayem G, Vilotitch A, Baud O, Ego A, Debillon T. Glycemia and Neonatal Encephalopathy: Outcomes in the LyTONEPAL (Long-Term Outcome of Neonatal Hypoxic EncePhALopathy in the Era of Neuroprotective Treatment With Hypothermia) Cohort. J Pediatr. 2023 Jun;257:113350. doi: 10.1016/j.jpeds.2023.02.003. Epub 2023 Feb 23.
- Derived from this study: PubMed 36272997Debillon T, Sentilhes L, Kayem G, Chevallier M, Zeitlin J, Baud O, Vilotitch A, Pierrat V, Guellec I, Ancel PY, Bednarek N, Ego A. Risk factors for unfavorable outcome at discharge of newborns with hypoxic-ischemic encephalopathy in the era of hypothermia. Pediatr Res. 2023 Jun;93(7):1975-1982. doi: 10.1038/s41390-022-02352-w. Epub 2022 Oct 22.
- Derived from this study: PubMed 36269426Beck J, Debillon T, Guellec I, Vilotitch A, Loron G, Bednarek N, Ancel PY, Pierrat V, Ego A. Healthcare organizational factors associated with delayed therapeutic hypothermia in neonatal hypoxic-ischemic encephalopathy: the LyTONEPAL cohort. Eur J Pediatr. 2023 Jan;182(1):181-190. doi: 10.1007/s00431-022-04666-7. Epub 2022 Oct 21.
- Derived from this study: PubMed 34802036Beck J, Bednarek N, Pierrat V, Vilotitch A, Loron G, Alison M, Guellec I, Hertz-Pannier L, de Launay C, Ego A, Vo-Van P, Ancel PY, Debillon T. Cerebral injuries in neonatal encephalopathy treated with hypothermia: French LyTONEPAL cohort. Pediatr Res. 2022 Sep;92(3):880-887. doi: 10.1038/s41390-021-01846-3. Epub 2021 Nov 20.
- Derived from this study: PubMed 30068301Debillon T, Bednarek N, Ego A; LyTONEPAL Writing Group. LyTONEPAL: long term outcome of neonatal hypoxic encephalopathy in the era of neuroprotective treatment with hypothermia: a French population-based cohort. BMC Pediatr. 2018 Aug 1;18(1):255. doi: 10.1186/s12887-018-1232-6.
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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.
Thierry DEBILLON, MD PhD principal investigator
University Hospital, Grenoble
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic-Hypoxic Encephalopathy, run by University Hospital, Grenoble at 22 sites 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 12 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
Results are not available in the source record.
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?
The primary outcome measure is a combined criterion : death, neurodevelopmental disabilities in survivors (time frame: between birth and 3 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676063, which also lists 11 linked publications.
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 6 Jun 2018.