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A clinical to study the effects of rapid and slow rewarming in treatment of moderate to severe hypothermic low birth weight newborns.

Rapid versus slow rewarming for management of moderate to severe hypothermia in low birth weight preterm neonates-a Randomised Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011187
Enrollment
100
Registered
2018-01-08
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- moderate to severely hypothermic low birth weight preterm neonates

Interventions

Intervention1: Rapid rewarming: rapid rewarming (@ 0.5 degree celcius per hour) under radiant warmer in servo control mode till the skin temperature reaches 36.5 degree celcius. Control Intervention1:
after that slow rewarming @0.5 degree celcius per hour till 36.5 degree celcius temperature. 2) If temperature between 34-35.9 degree celcius, keep under servo mode directly for slow rewarming @0.5 de

Sponsors

Pt B D Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • All low birth weight preterm neonates weighing

Exclusion criteria

Exclusion criteria: following neonates will be excluded from the study: • Preterm neonates with birth weight • Neonates with gross congenital malformations. • Neonatal death before achieving normothermia. • Parents/ legally acceptable representative (LAR) not giving consent to participate in the study. • Neonates with refractory shock.

Design outcomes

Primary

MeasureTime frame
1) Measured in terms of stabilization score (STABLE) at 6 hours and 24 hours of enrollment. 2)Mortality within 24 hours of enrollment.Timepoint: 6 hours and 24 hours of enrollment

Secondary

MeasureTime frame
1) Proportion of neonates who develop NEC,feed intolerance,apnoea,sepsis,need for intubation or respiratory support,shock. 2) Mortality during hospital stay after 24 hours of enrollment. 3)Time to reach normal body temperature. 4) Rewarmig rateTimepoint: 24 hours of enrollment

Countries

India

Contacts

Public ContactDr Prerana Jain

Pt B D Sharma PGIMS, Rohtak

jagjit.dr@gmail.com9968968980

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026