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

NCT ID: NCT01604434

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-10-31

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%.

Conditions

Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Incubator-no plastic bag

Placement into an incubator without a plastic bag

Group Type: SHAM_COMPARATOR

Incubator-no plastic bag

Intervention Type: PROCEDURE

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Incubator-torso bag

Placement into a plastic bag inside incubator

Group Type: ACTIVE_COMPARATOR

Incubator-torso bag

Intervention Type: PROCEDURE

While being placed into an 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 over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Interventions

Incubator-torso bag

While being placed into an 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 over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Intervention Type: PROCEDURE

Incubator-no plastic bag

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Infant admitted to the NICU
• Current weight between 1,000 and 2,500g
• Being placed in an incubator

Exclusion Criteria

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Health System, Alabama

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Wally Carlo

Edwin M. Dixon Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldemar A Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

UAB Neo 008

Identifier Type: -

Identifier Source: org_study_id