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Completed

NCT Number: NCT01604447

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

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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

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Key information

Age range

1 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Teaching Hospital

Lusaka, Zambia

About this study

Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant admitted to the NICU
  • Current weight less than 2,000g
  • Being removed from incubator

Exclusion criteria

  • Abdominal wall defect or myelomeningocele
  • Major congenital anomalies
  • Blistering skin disorder

Treatment and study plan

Hypothermia prevention with plastic bag

Procedure

Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Hypothermia prevention without plastic bag

Procedure

Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Primary outcomes

  1. Axillary temperature 36.5-37.5 degrees Celsius

    Time frame: 1-72 hours

    Temperature taken per axilla for one minute

Secondary outcomes

  1. Blood pressure

    Time frame: Up to 4 weeks

    Measure of extremity blood pressure per cuff taken during nursery stay

  2. Blood glucose

    Time frame: Up to 4 weeks

    Measure of blood glucose per laboratory value taken per heel stick

  3. Seizure

    Time frame: Up to 4 weeks

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

  4. Weight gain

    Time frame: Up to 4 weeks

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

  5. Respiratory Distress Syndrome (RDS)

    Time frame: Up to 4 weeks

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

  6. Bronchopulmonary Dysplasia (BPD)

    Time frame: 28 days after birth

    Oxygen requirement at 28 days of life

  7. Pneumothorax

    Time frame: Up to 4 weeks

    Either chest radiograph documentation or clinical deterioration consistent with air leak

  8. Sepsis

    Time frame: Up to 4 weeks

    Culture proven or culture negative clinically treated course consistent with sepsis

  9. Major brain injury

    Time frame: Up to 4 weeks

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

  10. Necrotizing enterocolitis or intestinal perforation

    Time frame: Up to 4 weeks

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

  11. Pulmonary hemorrhage

    Time frame: Up to 4 weeks

    Blood seen in the endotracheal tube and treated by physician

  12. Death

    Time frame: Up to 4 weeks

    Cardiorespiratory failure

  13. Hyperthermia

    Time frame: Up to 4 weeks

    Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute

  14. Length of time in incubator

    Time frame: Up to 4 weeks

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

  15. Room temperature and humidity

    Time frame: 1-72 hours

    A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

  16. Incubator temperature and humidity

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Children's of Alabama

Registry information

Official study title

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 23, 2012
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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