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A scientific study to know whether whole body cooling improves renal function in term newborns with respiratory distress

Effect of therapeutic hypothermia on renal function in term neonates with perinatal asphyxia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004053
Enrollment
120
Registered
2013-10-09
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 newborns with perinatal asphyxia

Interventions

Intervention1: THERAPEUTIC HYPOTHERMIA: 72 hrs of whole body cooling using cooling gel packs Control Intervention1: normal care: baby will be kept under warmer

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1,2,3+Any one of 4) 1.Gestational age >37 weeks 2.ABG(umblical cord or 1st postnatal hour pH 12meq 3.Evidence of encephalopathy(sarnat sarnat staging) 4.Any one of the following 1)APGAR 2)Assisted ventillation for ateast 10min after birth 3)evidence of any organ dysfunction

Exclusion criteria

Exclusion criteria: 1)infants >6hrs at time of randomisation 2)major congenital anomalies 3)if the newborn doesnot establish spontaneous respiration by 20minutes 4)outborn babies 5)maternal renal failure

Design outcomes

Primary

MeasureTime frame
To evaluate changes in renal function parameters by therapeutic hypothermia in perinatal asphyxiaTimepoint: 1 year—

Secondary

MeasureTime frame
1)To study renal parameters in term babies with perinatal asphyxia 2)To correlate renal parameters to outcome 3) To correlate renal parameters between hypothermia and normothermia babiesTimepoint: 1 year—

Countries

India

Contacts

Public ContactDr Vishnu bhat

JIPMER

vasanthan2k6jipmer@gmail.com9442360020

Outcome results

None listed

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