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Effects of reduced whole body temperature on DNA damage in new born babies having birth asphyxia

Effect of therapeutic hypothermia on DNA damage in term babies with perinatal asphyxia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/10/002094
Enrollment
120
Registered
2011-10-28
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 new borns with perinatal asphyxia

Interventions

Intervention1: Hypothermia : Babies will be cooled using cloth covered cooling gel packs to achieve a target temperature of 33°C-34°C. This temperature will be maintained by continuous rectal and s

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. APGAR 4. Any one of the following i. Evidence of encephalopathy (THOMPSON SCORE >5) 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 prolapsed, 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. Out born babies

Design outcomes

Primary

MeasureTime frame
DNA DAMAGE AT 72 HOURS OF LIFE DEVELOPMENTAL FOLLOW UP TILL ONE YEAR OF AGETimepoint: DNA DAMAGE AT 72 HOURS OF LIFE

Secondary

MeasureTime frame
DEVELOPMENTAL FOLLOW UP TILL ONE YEAR OF AGETimepoint: one year

Countries

India

Contacts

Public ContactDr Vishnu Bhat

JIPMER

drvishnubhat@yahoo.com09489692400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 10, 2026