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

Not Applicable
Withdrawn
Conditions
Hypothermia
Interventions
Procedure: Incubator-no plastic bag
Procedure: Incubator-torso bag
Registration Number
NCT01604434
Lead Sponsor
University of Alabama at Birmingham
Brief Summary

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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Detailed Description

Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Infant admitted to the NICU
  • Current weight between 1,000 and 2,500g
  • Being placed in an incubator
Read More
Exclusion Criteria
  • Abdominal wall defect or myelomeningocele
  • Major congenital anomalies
  • Blistering skin disorder
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Incubator-no plastic bagIncubator-no plastic bagPlacement into an incubator without a plastic bag
Incubator-torso bagIncubator-torso bagPlacement into a plastic bag inside incubator
Primary Outcome Measures
NameTimeMethod
Axillary temperature 36.5-37.5 degrees Celsius1-72 hours

Temperature taken per axilla for 1 minute

Secondary Outcome Measures
NameTimeMethod
Blood PressureUp to 4 weeks

Measure of extremity blood pressure per cuff taken during nursery stay

SeizureUp to 4 weeks

Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

Weight gainUp to 4 weeks

Infant will be weighed daily and rates of weight gain will be calculated

Blood glucoseUp to 4 weeks

Measure of blood glucose per laboratory value taken per heel stick

Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)Up to 4 weeks

Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

Bronchopulmonary dysplasia (BPD)28 days after birth

Oxygen requirement at 28 days after birth

PneumothoraxUp to 4 weeks

Either chest radiograph documentation or clinical deterioration consistent with air leak

SepsisUp to 4 weeks

Culture proven or culture negative clinically treated course consistent with sepsis

Major brain injuryUp to 4 weeks

Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound

Necrotizing enterocolitis or intestinal perforationUp to 4 weeks

Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.

Pulmonary hemorrhageUp to 4 weeks

Blood seen in the endotracheal tube and treated by physician

DeathUp to 4 weeks

Cardiorespiratory failure

HyperthermiaUp to 4 weeks

Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for one minute

Length of time in IncubatorUp to 4 weeks

Documentation of length of time spent in incubator and number of times placed in incubator

Temperature and humidity1 hour

A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement

Trial Locations

Locations (1)

University Teaching Hospital

🇿🇲

Lusaka, Zambia

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