Skip to main content
OpenTrials
Completed

NCT Number: NCT01403623

Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Teaching Hospital

Lusaka, Zambia

About this study

Prevention

After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
  • Delivery in the hospital.

Exclusion criteria

  • Abdominal wall defect or myelomeningocele.
  • Major congenital anomaly.
  • Blistering skin disorder.

Treatment and study plan

Resuscitation and post resuscitation care with plastic bag

Procedure

Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Resuscitation- no plastic bag for temperature regulation

Procedure

Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Primary outcomes

  1. Axillary temperature 36.5-37.5 degrees Celsius

    Time frame: 1-4 hours

    Temperature taken per axilla for 1 minute

Secondary outcomes

  1. Blood pressure

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Measure of extremity blood pressure per cuff taken during nursery stay.

  2. Blood glucose

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Measure of blood glucose per laboratory value taken per heelstick

  3. Seizure

    Time frame: Duration of hospitalization-expected average of 4 weeks

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

  4. Weight gain

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Infant will be weighed daily and rates of weight gain will be measured.

  5. Respiratory Distress Syndrome (RDS)

    Time frame: Duration of hospitalization-expected average of 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: Duration of hospitalization-expected average of 4 weeks

    Either chest radiograph documentation or clinical deterioration consistent with air leak

  8. Sepsis

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Culture proven or culture negative clinically treated course consistent with sepsis.

  9. Major brain injury

    Time frame: Duration of hospitalization-expected average of 4 weeks

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

  10. Necrotizing enterocolitis or intestinal perforation

    Time frame: Duration of hospitalization-expected average of 4 weeks

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

  11. Pulmonary hemorrhage

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Blood seen in the endotracheal tube and treated by physician.

  12. Death

    Time frame: Duration of hospitalization-expected average of 4 weeks

    Cardiorespiratory failure

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 27, 2011
Registry last updated
Aug 21, 2013

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.

Published trials that share one or more normalized conditions with this study.