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Effect of Therapeutic hypothermia on myocardial function in term neonates with perinatal asphyxia

Effect of therapeutic hypothermia on myocardial dysfunction in term neonates with perinatal asphyxia - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/09/007257
Enrollment
120
Registered
2016-09-08
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- patients (new born babies) who were asphyxiated at birth means not cried at birth

Interventions

Intervention1: cooling material: techotherm and phasechanging material Intervention2: therapeutic hypothermia: techotherrm phase changing material Intervention3: therapeutic hypothermia: whole body hy

Sponsors

Dr Vishnubhat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Inclusion Criteria (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 (Sarnat staging) 4. Any one of the following i. APGAR ii. Assisted ventilation for at least 10 min after birth iii. Evidence of any organ dysfunction iv. History of acute perinatal event- intra partum fetal distress, cord prolapse placental abruption.

Exclusion criteria

Exclusion criteria: 1. Infants >6 hours of age at the time of randomization 2. Major congenital abnormalities 3. No spontaneous respiration by 20 minutes 4. Extramural babies

Design outcomes

Primary

MeasureTime frame
1. To study the effect of hypothermia on myocardial ejection fraction and myocardial enzyme profile in term newborns with perinatal asphyxiaTimepoint: 0&72 hrs ECHO for ejection fraction 0&24&72 hrs for enzyme profile

Secondary

MeasureTime frame
1. To correlate the change in myocardial ejection fraction and myocardial enzyme profile with severity of asphyxia and neuro developmental outcome at 18 months.Timepoint: 18 months

Countries

India

Contacts

Public ContactVishnu Bhat

jipmer

drvishnubhat@yahoo.com988822113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026