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Effect of temperature on oxidative stress on birth asphyxia in term babies

Effect of therapeutic hypothermia on oxidative stress in term neonates with perinatal asphyxia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002196
Enrollment
58
Registered
2011-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- term neonates with perinatal asphyxia

Interventions

Intervention1: Therapeutic hypothermia: After taking the informed written consent from the parents of the newborns fulfilling the inclusion criteria, allocation of participants to specific treatment g

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn babies with : 1+2+3 + any one of 4 1. Gestational, age >= 37 weeks 2. ABG(umbilical cord or 1st postnatal hour pH = 12meq 3. Evidence of encephalopathy (THOMPSON SCORE >5) 4. Any one of the following i. APGAR ii. Evidence of fetal distress iii. Assisted ventilation for at least 10 min after birth iv. Evidence of any organ dysfunction v. History of acute perinatal event- intrapartum fetal distress, cord prolapse placental abruption ,uterine rupture, maternal trauma,cardiac arrest

Exclusion criteria

Exclusion criteria: i. Infants >6 hours of age at the time of randomisation ii. Major congenital abnormalities iii. If the baby does not establish spontaneous respiration by 20 minutes iv. outborn babies

Design outcomes

Primary

MeasureTime frame
Level of Total antioxidant status(TAS), Malondialdehyde (MDA)in both the groups.Timepoint: At birth and at 72 hours of age in both groups

Secondary

MeasureTime frame
Death, neurological disability at discharge in both the groups Timepoint: followed up till discharge from hospital

Countries

India

Contacts

Public ContactDr Vishnu Bhat

JIPMER

drvishnubhat@yahoo.com09842351282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 25, 2026