Hypothermia
Conditions
Keywords
Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress
Brief summary
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.
Interventions
DEVICENeoWrap
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
DEVICEInfaTherm
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 28 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and \<1250g.
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. * Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams * Anencephaly * Confirmed Trisomy 13 or Trisomy 18 syndrome * Meconium staining of amniotic fluid * Birth assessment of gestational age \> 28 weeks or \>1250 grams * Maternal temp \>38 degrees C around the time of delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Intensive Care Unit (NICU) Admission Temperature | At time of admission to the NICU - usually within 10-15 min of birth | Axillary temperature of the infant upon arrival to the neonatal intensive care unit. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Blanket This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery. | 20 |
| Wrap This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Blanket | Wrap |
|---|---|---|---|
| Age, Categorical <=18 years | 39 Participants | 20 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 39 participants | 20 participants | 19 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 24 Participants | 13 Participants | 11 Participants |
| Temperature | 36.3 Celsius degrees STANDARD_DEVIATION 0.66 | 36.5 Celsius degrees STANDARD_DEVIATION 0.67 | 36.1 Celsius degrees STANDARD_DEVIATION 0.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Neonatal Intensive Care Unit (NICU) Admission Temperature
Axillary temperature of the infant upon arrival to the neonatal intensive care unit.
Time frame: At time of admission to the NICU - usually within 10-15 min of birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blanket | Neonatal Intensive Care Unit (NICU) Admission Temperature | 36.5 Celsius degrees | Standard Deviation 0.67 |
| Wrap | Neonatal Intensive Care Unit (NICU) Admission Temperature | 36.1 Celsius degrees | Standard Deviation 0.66 |
p-value: 0.445t-test, 1 sided