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

Study Overview
=================
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 V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Detailed Description
-----------------
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

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

Conditions
-----------------
Hypothermia, Newborn

Intervention / Treatment
-----------------
* Procedure: Resuscitation with torso plastic bag
* Procedure: Resuscitation-no plastic bag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated gestational age 37 weeks and greater Birth weight greater than 2,500gms Delivery in the hospital Exclusion Criteria: Infant admitted to the NICU Birth weight less than 2,500gms Abdominal wall defect or myelomeningocele Major congenital anomalies Blistering skin disorder

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 72 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Resuscitation-no plastic bag<br>Resuscitation per standard of care without a plastic bag | Procedure: Resuscitation-no plastic bag<br>* Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.<br>|
| Active Comparator: Resuscitation-torso bag<br>Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth | Procedure: Resuscitation with torso plastic bag<br>* Infant will be placed within 10 minutes of his birth 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. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature < 36.5 degrees Celsius | Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and < 32.0 will be classified as severe hypothermia. | 1-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis | Culture proven or culture negative clinically treated course consistent with sepsis | Up to 72 hours | 
| Death | Cardiorespiratory failure | Up to 72 hours | 
| Hyperthermia | Axillary temperature > 38 degrees Celsius per axilla for one minute | Up to 72 hours | 
| Room Temperature | A recording of the room temperature will be obtained with each axillary temperature measurement | 1-72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypothermia, Newborn, Plastic bag, Resuscitation