Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blanket | Experimental | This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery. |
|
| Wrap | Experimental | This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoWrap | Device | This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Intensive Care Unit (NICU) Admission Temperature | Axillary temperature of the infant upon arrival to the neonatal intensive care unit. | At time of admission to the NICU - usually within 10-15 min of birth |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
Blistering skin conditions
Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):
Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Dannaway, MD | University of Oklahoma | Principal Investigator |
| Parker L Simon, DO, MPH | University of Oklahoma | Study Director |
| Marilyn Escobedo, MD | University of Oklahoma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
Three enrolled babies were not included in the analysis. One was found to have a birth weight greater than the cut-off, one was randomized to the wrong group, and one had an unrecorded delivery room temperature.
Mothers were approached on the labor and delivery floor to consent for their child's participation in this study. Recruitment took place from May 2007 to November 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Blanket | This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery. |
| FG001 | Wrap | This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Blanket | This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery. |
| BG001 | Wrap | This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neonatal Intensive Care Unit (NICU) Admission Temperature | Axillary temperature of the infant upon arrival to the neonatal intensive care unit. | Posted | Mean | Standard Deviation | Celsius degrees | At time of admission to the NICU - usually within 10-15 min of birth |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blanket | This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery. |
Not provided
Not provided
Technical difficulties with the polyethylene wrap were the main limitations (variation of use, heat loss during pulse oximeter adjustment).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Dannaway, MD | University of Oklahoma Health Sciences Center | 405-271-5215 | 42048 | douglas-dannaway@ouhsc.edu |
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| InfaTherm | Device | A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Temperature | Mean | Standard Deviation | Celsius degrees |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Wrap | This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. | 0 | 0 | 0 | 0 |
Not provided
Not provided