R Christina Catherine1, B Vishnu Bhat2,3, B Adhisivam1, Shruthi K Bharadwaj1, Vickneshwaran Vinayagam4, Palanivel Chinnakali5. 1. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. 2. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. drvishnubhat@yahoo.com. 3. Department of Pediatrics and Neonatology, AVMC, Kirumampakkam, Puducherry, 607402, India. drvishnubhat@yahoo.com. 4. Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India. 5. Department of Preventive & Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Abstract
OBJECTIVE: To assess whether serum levels of neuronal biomarkers (S100 calcium-binding protein B and Neuron specific enolase) correlate with the neurodevelopmental outcome of term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia. METHODS: This randomized controlled trial was conducted in a tertiary care teaching hospital, south India. There were 162 term infants with moderate to severe hypoxic ischemic encephalopathy who were randomized into 2 groups (Group A and B). Neonates in Group A and B received normothermia and therapeutic hypothermia respectively. Serum levels of neuronal biomarkers were estimated at 0, 24 (±1) and 72 (±1) h after birth using sandwich ELISA in both groups. All neonates were carefully monitored till discharge. Infants who survived the neonatal period were followed up in the high risk clinic for 18 mo and neurodevelopmental assessment was done using Developmental Assessment Scale for Indian Infants (DASII). Neurodevelopmental outcomes between the two groups were compared using Chi square test and neuronal biomarker levels between the groups were compared using Mann Whitney test. RESULTS: The baseline maternal and neonatal characteristics in both groups were comparable. There was statistically insignificant lesser mortality in therapeutic hypothermia group compared to normothermia group with Risk Ratio (RR): 0.82 (28.2% vs. 34.5%, 95% CI: 0.52-1.29, p = 0.38). Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo. There was no significant correlation between S100B and Neuron specific enolase levels and neurodevelopmental outcome. CONCLUSIONS:Serum levels of neuronal biomarkers (S100B and Neuron specific enolase) do not correlate with the long term neurodevelopmental outcome among these infants.
RCT Entities:
OBJECTIVE: To assess whether serum levels of neuronal biomarkers (S100 calcium-binding protein B and Neuron specific enolase) correlate with the neurodevelopmental outcome of term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia. METHODS: This randomized controlled trial was conducted in a tertiary care teaching hospital, south India. There were 162 term infants with moderate to severe hypoxic ischemic encephalopathy who were randomized into 2 groups (Group A and B). Neonates in Group A and B received normothermia and therapeutic hypothermia respectively. Serum levels of neuronal biomarkers were estimated at 0, 24 (±1) and 72 (±1) h after birth using sandwich ELISA in both groups. All neonates were carefully monitored till discharge. Infants who survived the neonatal period were followed up in the high risk clinic for 18 mo and neurodevelopmental assessment was done using Developmental Assessment Scale for Indian Infants (DASII). Neurodevelopmental outcomes between the two groups were compared using Chi square test and neuronal biomarker levels between the groups were compared using Mann Whitney test. RESULTS: The baseline maternal and neonatal characteristics in both groups were comparable. There was statistically insignificant lesser mortality in therapeutic hypothermia group compared to normothermia group with Risk Ratio (RR): 0.82 (28.2% vs. 34.5%, 95% CI: 0.52-1.29, p = 0.38). Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo. There was no significant correlation between S100B and Neuron specific enolase levels and neurodevelopmental outcome. CONCLUSIONS: Serum levels of neuronal biomarkers (S100B and Neuron specific enolase) do not correlate with the long term neurodevelopmental outcome among these infants.
Authors: Sabahattin Ertuğrul; Savaş Mert Darakci; İbrahim Kaplan; İlyas Yolbaş; İbrahim Deger; Sibel Tanrıverdi Yilmaz; Şerafettin Aktaş Journal: Turk J Med Sci Date: 2021-08-30 Impact factor: 0.973