Therapeutic Hypothermia for birth Asphyxia using Revive servo-controlled device â?? a randomised controlled trial.
- Conditions
- Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
- Registration Number
- CTRI/2020/06/025902
- Lead Sponsor
- Sensivision Health Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
i. Inborn baby with GA >= 36 weeks and BW >= 2000 grams
ii. Age less than 6 hours
iii. Umbilical arterial (or gas within 1 hour of life) pH <=7 or Base deficit >= 12 meq/L. If blood gas is unavailable, then any one of the following can be used
a) APGAR <= 5 at 10 min
b) Assisted ventilation for at least 10 min after birth
c) History of acute perinatal event- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
iv. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat & Sarnat staging) consisting of:
a) Seizures b) Altered state of consciousness (reduced or absent response to stimulation) c) Abnormal tone (focal or general hypotonia, or flaccid) d) Abnormal primitive reflexes
(weak or absent suck or Moro response)
1) Major congenital abnormalities
2) Babies who fail to establish spontaneous respiration at 20 minutes of life
3) Absent heart rate at 10 min of age despite adequate resuscitation
4) Risk of imminent death
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method