Health Condition 1: P916- Hypoxic ischemic encephalopathy [HIE]
Conditions
Interventions
Intervention1: Servo-controlled Whole Body Cooling: This device will automatically perform whole body cooling non-invasively by monitoring the core body temperature of the baby using rectal means.
Con
Sponsors
Sensivision Health Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 = 12 meq/L. If blood gas is unavailable, then any one of the following can be used a) APGAR 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective cooling time (increased cooling effectiveness through effectively maintaining the the rectal temperature within the target temperature range of 33°C to 34°C during the maintenance.)Timepoint: Continuous rectal temperature monitoring until 90 hours of age, and then every 8 h for the first week after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to induction of cooling - Mortality from any cause before discharge from hospital - Gastric bleeds - Persistent hypotension - Pulmonary haemorrhage - Persistent pulmonary hypertension - Bleeding diathesis requiring blood products - Culture-proven early onset sepsis - Necrotizing enterocolitis - Cardiac arrhythmia requiring therapy - Severe thrombocytopenia (25,000/mm3) - Renal failure (anuria 48 h with azotemia) - Subcutaneous fat necrosisTimepoint: Before discharge from hospital | — |
Countries
India
Contacts
Public ContactDr G Guruprasad
J.J.M Medical College
Outcome results
None listed