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

Purpose

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.

Condition	Intervention	Phase
Hypothermia	Procedure: Hypothermia prevention with plastic bag Procedure: Hypothermia prevention without plastic bag	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]
Temperature taken per axilla for one minute

Secondary Outcome Measures:

Blood pressure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Measure of extremity blood pressure per cuff taken during nursery stay
Blood glucose [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Measure of blood glucose per laboratory value taken per heel stick
Seizure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
Weight gain [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Infant will be weighed daily and rates of weight gain will be calculated
Respiratory Distress Syndrome (RDS) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days after birth ] [ Designated as safety issue: Yes ]
Oxygen requirement at 28 days of life
Pneumothorax [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Either chest radiograph documentation or clinical deterioration consistent with air leak
Sepsis [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Culture proven or culture negative clinically treated course consistent with sepsis
Major brain injury [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Necrotizing enterocolitis or intestinal perforation [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.
Pulmonary hemorrhage [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Blood seen in the endotracheal tube and treated by physician
Death [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Cardiorespiratory failure
Hyperthermia [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
Length of time in incubator [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
Documentation of length of time spent in incubator and number of times placed in incubator
Room temperature and humidity [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Incubator temperature and humidity [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement

Estimated Enrollment:	118
Study Start Date:	June 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Incubator removal-torso bag Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator	Procedure: Hypothermia prevention with plastic bag 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.
Placebo Comparator: Incubator removal-no plastic bag Standard bundling practices when removing the infant from the incubator. No plastic bag used.	Procedure: Hypothermia prevention without plastic bag 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.

Arms

Assigned Interventions

Active Comparator: Incubator removal-torso bag

Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator

Procedure: Hypothermia prevention with plastic bag

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.

Placebo Comparator: Incubator removal-no plastic bag

Standard bundling practices when removing the infant from the incubator. No plastic bag used.

Procedure: Hypothermia prevention without plastic bag

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.

Detailed Description:

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%.

Eligibility

Ages Eligible for Study:	up to 72 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604447

Contacts

Contact: Waldemar A Carlo, MD	205 934-4680	wcarlo@peds.uab.edu
Contact: Theodore C Belsches, MS4	334-798-1544	tcb7@uab.edu

Locations

Zambia
University Teaching Hospital	Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MD echomba@zamnet.zm
Sub-Investigator: Theodore C Belsches, MS4
Sub-Investigator: Rohan Kambeyanda, MS4
Sub-Investigator: Tonya R. Miller, MS4
Sub-Investigator: Alyssa E Tilly, MS4

Sponsors and Collaborators

University of Alabama at Birmingham

Childrens of Alabama

Investigators

Principal Investigator:

Waldemar A Carlo, MD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	Waldemar A. Carlo, MD, Edwin M. Dixon Professor of Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01604447 History of Changes
Other Study ID Numbers:	UAB Neo 009
Study First Received:	May 21, 2012
Last Updated:	February 8, 2013
Health Authority:	United States: Institutional Review Board Zambia: Research Ethics Committee

Keywords provided by University of Alabama at Birmingham:

Hypothermia
Newborn
Incubator
Plastic bag
Normothermia

Additional relevant MeSH terms:

Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013