An observational study in Ischemic-Hypoxic Encephalopathy, sponsored by University Hospital, Grenoble. Status unknown at 22 sites in France. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by University Hospital, Grenoble · Observational
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:
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).
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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.
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:
Exclusion Criteria:
moderate or severe HIE among term and late preterm newborn
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 : 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
Time frame: between birth and 3 years of age
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
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.
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.
Time frame: 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
Time frame: 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
Time frame: birth
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University Hospital, Grenoble