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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resuscitation with plastic bag | Active Comparator | Plastic bag will be used during and after resuscitation to assist with temperature regulation. |
|
| Standard resuscitation- no plastic bag | Sham Comparator | Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary temperature 36.5-37.5 degrees Celsius | Temperature taken per axilla for 1 minute | 1-4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measure of extremity blood pressure per cuff taken during nursery stay. | Duration of hospitalization-expected average of 4 weeks |
| Blood glucose | Measure of blood glucose per laboratory value taken per heelstick |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Study Director |
| Alicia E Leadford, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23733796 | Derived | Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3. |
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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 |
|---|---|
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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|
| 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. |
|
| Duration of hospitalization-expected average of 4 weeks |
| Seizure | Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. | Duration of hospitalization-expected average of 4 weeks |
| Weight gain | Infant will be weighed daily and rates of weight gain will be measured. | Duration of hospitalization-expected average of 4 weeks |
| Respiratory Distress Syndrome (RDS) | Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant. | Duration of hospitalization-expected average of 4 weeks |
| Bronchopulmonary dysplasia (BPD) | Oxygen requirement at 28 days of life | 28 days after birth |
| Pneumothorax | Either chest radiograph documentation or clinical deterioration consistent with air leak | Duration of hospitalization-expected average of 4 weeks |
| Sepsis | Culture proven or culture negative clinically treated course consistent with sepsis. | Duration of hospitalization-expected average of 4 weeks |
| Major brain injury | Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound | Duration of hospitalization-expected average of 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 stage greater than one. | Duration of hospitalization-expected average of 4 weeks |
| Pulmonary hemorrhage | Blood seen in the endotracheal tube and treated by physician. | Duration of hospitalization-expected average of 4 weeks |
| Death | Cardiorespiratory failure | Duration of hospitalization-expected average of 4 weeks |