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no personnel available to enroll patients- decision made to not complete study
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| Name | Class |
|---|---|
| Children's Health System, Alabama | OTHER |
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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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.
Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermoregulation-standard care | Sham Comparator | Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first. |
|
| Thermoregulation-with plastic bag | Active Comparator | Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermoregulation-standard care | Procedure | Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary temperature < 36.5 degrees Celsius | Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and <32.0 as severe hypothermia. | Discharge or 24 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure | Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done. | Up to 4 weeks |
| Respiratory Distress Syndrome (RDS) | Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital | Lusaka | Zambia |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001833 | Body Temperature Regulation |
| ID | Term |
|---|---|
| D001831 | Body Temperature |
| D010829 | Physiological Phenomena |
| D006706 | Homeostasis |
| D000222 | Adaptation, Physiological |
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| Thermoregulation with plastic bag | Procedure | One hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first. |
|
| Up to 4 weeks |
| Pneumothorax | Either chest radiograph documentation or clinical deterioration consistent with air leak | Up to 4 weeks |
| Sepsis | Culture proven or culture negative clinically treated course consistent with sepsis | Up to 4 weeks |
| Necrotizing enterocolitis or intestinal perforation | Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1. | Up to 4 weeks |
| Death | Cardiorespiratory failure | Up to 4 weeks |
| Hyperthermia | Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute | Up to 4 weeks |
| Temperature and humidity | A recording of the room temperature and humidity will be obtained with each axillary temperature measurement | 1-72 hours after birth |
| D000220 |
| Adaptation, Biological |
| D001686 | Biological Phenomena |