Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dr Nishant Banait
Dr Amit Kumar
Dr Ashwini Umredkar
Dr Richa Juneja
Eligibility
Inclusion criteria
Inclusion criteria: 1.Cases: 1. 37 week and 0 day to 42week and 6 days gestational age and more than 1.8kgs 2. Evidence of asphyxia as defined by the presence of at least two of the following four criteria: A. Apgar less than 5 at 10 minutes or continued need for resuscitation with positive pressure ventilation with or without chest compressions at 10 minutes of age B. Any acute perinatal event that may result in HIE (abruption placenta, cord prolapse, severe foetal heart rate abnormality.). C. Cord pH less than 7.1 or base deficit of 12 or more within 60 minutes of birth D. If cord pH is not available, arterial/ capillary/ venous pH less than 7.1 or BE more than 12 mmol/L within 60 minutes of birth 3. Clinical signs of HIE 4. aEEG suggestive of HIE 2.Controls: 1.37 week and 0 day to 42week and 6 day gestational age and more than 1.8kgs 2. Normal cord blood gas analysis (pH more than 7.20, base deficit less than 16 mmol/L). 3. Apgar score more than 7 at 5 minutes.
Exclusion criteria
Exclusion criteria: Cases: 1.Neonates with congenital anomalies or chromosomal abnormalities. 2.Neonates from multiple pregnancies. 3.Parents not giving consent for participation. Controls 1.Neonates with congenital anomalies or chromosomal abnormalities. 2.Neonates from multiple pregnancies. 3.Maternal infections/ chorioamnionitis at the time of birth. 4.Presence of fetal distress. 5.Maternal gestational diabetes mellitus, hypertension. 6.Parents not giving consent for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between CD34+ cell levels and HIE severity: 1.Comparison of CD34+ cell levels in umbilical cord blood between neonates with perinatal asphyxia who has HIE and neonates without perinatal asphyxia. 2.To compare CD34+ cell levels in term neonates with mild, moderate and severe HIE using Thompson scoring at 6 hours. 3.Correlation between CD34+ cell count and aEEG findings of patients with moderate to severe HIE Timepoint: At birth, 1 hour of life , 6 hour of life then 6 houuly till 72 hours of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality: Evaluation of CD34+ cell levels & nRBCs as a predictor of mortality in neonates with moderate-to-severe HIE. 2. Neurodevelopmental Impairment: Correlation between CD34+ cell levels & neurodevelopmental outcomes at discharge (HNNE Score). 3. Neuroimaging: Correlation of CD34+ cell levels & nRBCs with MRI Brain & MR Spectroscopy findings between 8 to 14 days of life in cases with moderate to severe HIE. 4. Correlation of CD34+ cell levels & nRBCs with acute & chronic perinatal asphyxia. Timepoint: At 1 hour of life, MRI before 14 days of life in cases. HNNE score at the time of discharge | — |
Countries
India
Contacts
Public ContactDr Nishant Banait
All India Institute of Medical Sciences Nagpur
Outcome results
None listed