Trial Outcomes & Findings for Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns. (NCT NCT00603837)
NCT ID: NCT00603837
Last Updated: 2009-10-16
Results Overview
Axillary temperature of the infant upon arrival to the neonatal intensive care unit.
COMPLETED
NA
36 participants
At time of admission to the NICU - usually within 10-15 min of birth
2009-10-16
Participant Flow
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.
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.
Participant milestones
| Measure |
Blanket
This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
|
Wrap
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Blanket
This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
|
Wrap
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Baseline characteristics by cohort
| Measure |
Blanket
n=20 Participants
This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
|
Wrap
n=19 Participants
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Temperature
|
36.5 Celsius degrees
STANDARD_DEVIATION 0.67 • n=5 Participants
|
36.1 Celsius degrees
STANDARD_DEVIATION 0.66 • n=7 Participants
|
36.3 Celsius degrees
STANDARD_DEVIATION 0.66 • n=5 Participants
|
PRIMARY outcome
Timeframe: At time of admission to the NICU - usually within 10-15 min of birthAxillary temperature of the infant upon arrival to the neonatal intensive care unit.
Outcome measures
| Measure |
Blanket
n=17 Participants
This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
|
Wrap
n=19 Participants
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
|
|---|---|---|
|
Neonatal Intensive Care Unit (NICU) Admission Temperature
|
36.5 Celsius degrees
Standard Deviation 0.67
|
36.1 Celsius degrees
Standard Deviation 0.66
|
Adverse Events
Blanket
Wrap
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doug Dannaway, MD
University of Oklahoma Health Sciences Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place