Associate Professor of Pediatrics University of Oklahoma Health Sciences Center The University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States
Background: Neonatal hypothermia ( < 36.5C) at admission has been associated with an increased risk of morbidity and mortality. Objective: To evaluate the safety and effectiveness of warming moderate and late preterm neonates delivered via cesarean during delayed umbilical cord clamping (dUCC). Design/Methods: Parallel group randomized controlled pilot trial with block randomization stratified for two gestational age groups -32w0d-34w6d and 35w0d-36w6d. The control and intervention groups underwent dUCC for 60 seconds at the time of cesarean; if considered safe by both pediatric and obstetric providers. Neonates in the intervention group were placed in a polyethylene suit above a chemical warming mattress during the dUCC period. The devices were removed at the resuscitation warmer. Axillary temperature was measured at arrival to the warmer, completion of resuscitation and arrival to the neonate's room. Results: 52 patients were randomized, and two were excluded prior to delivery. Modified Poisson regression, adjusting for stratum and time from delivery to the warmer, demonstrated that the risk of hypothermia at the warmer was not significantly altered, RR 2.71 (95% CI 0.70, 10.51). Of note, the risk of hypothermia at arrival to the neonate’s room had a RR of 0.60 (95% CI 0.28-1.29), and NICU admission had a RR of 0.81 (95% CI 0.64-1.02). Much of the effect was attributed to lower risk of moderate hypothermia ( < 36.0C), RR 0.24 (95% CI 0.03, 1.92). Other secondary outcomes including hypoglycemia, highest bilirubin level, form of respiratory support, pulmonary hemorrhage, hyperthermia (>37.5C), length of stay, and composite neonatal morbidity and mortality (outcomes of death, intraventricular hemorrhage and sepsis) did not reach significance with wide confidence intervals.
Conclusion(s): While the intervention did not demonstrate an improvement in temperature at the warmer among moderate and late preterm neonates delivered via cesarean, there may be an improvement in admission temperatures and NICU admissions. These pilot results will inform the design of a well-powered multi-center trial for hypothermia prevention.