Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2026-08-15

Brief Summary

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The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

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Detailed Description

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This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Conditions

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Hypothermia Immature Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Resuscitation-torso plastic bag

Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.

Group Type ACTIVE_COMPARATOR

Resuscitation-torso plastic bag

Intervention Type PROCEDURE

Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Resuscitation-partial-head plastic bag

Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.

Group Type ACTIVE_COMPARATOR

Resuscitation-partial-head plastic bag

Intervention Type PROCEDURE

Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Interventions

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Resuscitation-torso plastic bag

Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Intervention Type PROCEDURE

Resuscitation-partial-head plastic bag

Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
* Delivery in the hospital

Exclusion Criteria

* Infant admitted to the NICU
* Birth weight less than 1,400g
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder

Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No