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To study the impact of polyethylene zip lock wrap v/s routine cloth wrap on neonatal hypotherma during and after transport to higher centre

Proof-of-concept field trial to assess the impact of polyethylene wrap v/s routine cloth wrap in reducing postnatal hypothermia in preterm and low-birth weight neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009065
Enrollment
256
Registered
2017-07-17
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: P969- Condition originating in the perinatal period, unspecified Health Condition 2: null- Preterm and low birth newborns delivered at sub centers, primary health centers and community heath center and need referral to higher center for any reason.

Interventions

Intervention1: Polyethylene wrap: Food grade polyethylene bag with zip lock Control Intervention1: Any conventional method to cover the newborn: Usually cloth is used as a conventional method to wrap

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: First three days of life, birth weight below 2500 gm , preterm newborns

Exclusion criteria

Exclusion criteria: Abdominal wall defect, myelomeningocele, major congenital anomaly, blistering skin disorder, Neonates more than three days of age, Full term, Birth weight more than 2499 gm

Design outcomes

Primary

MeasureTime frame
The presence of hypothermia before the baby is placed under the warmer at the referred Newborn care unitTimepoint: Within 2 months after collecting the data. Data collection would take 12 months.

Secondary

MeasureTime frame
Frequency of hypothermia, Frequency of hyperthermia, frequency of hypoglycaemia at destination, duration of admission at referred centre, and mortality.Timepoint: Temperature will be recorded at 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours and at 48 hours after keeping under radiant warmer at referred centre. Other parameters will be recorded for the overall period of admission at the referred centre.

Countries

India

Contacts

Public ContactDr Somashekhar Nimbalkar

Pramukhswami Medical College

somu_somu@yahoo.com9825087842

Outcome results

None listed

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