Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
Conditions
Interventions
Intervention1: N-Acetylcysteine: 25-40 mg/kg/day, for 10 days of life or discharge
Control Intervention1: Placebo: 25-40 mg/kg/day, for 10 days of life or discharge
Sponsors
Nagireddy Sainadh
Eligibility
Inclusion criteria
Inclusion criteria: Newborn infants of 35 weeks gestation or greater having perinatal asphyxia APGAR scores less than or equal to 5 at 5 min of life, Acidosis within 60 min of birth (cord pH or arterial pH less than 7.1 or a base deficit of 12 or above) Need for mechanical ventilation or resuscitation at 10 min of birth.
Exclusion criteria
Exclusion criteria: Presumed IEM and genetic disorders Major congenital abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the usefullness of N Acetylcysteine as a neuroprotective role in hypoxic ischemic encephalopathy.Timepoint: 6 months to 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess short term Neurological outcomes in Babies with hypoxic ischemic encephalopathy by using HNNE score, need for anti epileptic drugs, and MRI Brain.Timepoint: 6 months to 1 year;To assess long term Neurological outcomes in Babies with hypoxic ischemic encephalopathy by using DASII score, HINE score.Timepoint: 6 months to 1 year | — |
Countries
India
Contacts
Public ContactDr Meena Patel
Shyam Shah Medical College
Outcome results
None listed