N/A
N=52
Neonatal Warming to Prevent Hypothermia
Hypothermia
Bottom Line
View on ClinicalTrials.gov: NCT04827394 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Temperature at Arrival to Warmer — 36.9; 37.0 degrees Celsius
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neonatal warming mattress (Device); Sterile polyethylene wrap (Device)
- Age
- Pediatric, Adult
- Sex
- Female
- Sponsor
- University of Oklahoma
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature at Arrival to Warmer |
36.9; 37.0 | — |
| SECONDARY Temperature at Exit |
36.8; 36.7 | — |
| SECONDARY Temperature at NICU/Recovery |
36.6; 36.5 | — |
| SECONDARY Peak Bilirubin |
9.0; 9.0 | — |
| SECONDARY Duration of Respiratory Support |
114.3; 31.2 | — |
| SECONDARY Length of Delayed Cord Clamp |
61.0; 62.0 | — |
| SECONDARY Length of Hospital Stay |
11.0; 7.0 | — |
| SECONDARY Age to Wean to Crib |
3.0; 1.0 | — |
| SECONDARY Hypothermia at Warmer |
6; 2 | — |
| SECONDARY Hypothermia at Completion of Resuscitation |
6; 3 | — |
| SECONDARY Hypothermia at NICU/Recovery |
7; 11 | — |
| SECONDARY Hyperthermia (>37.5C) at Warmer |
2; 1 | — |
| SECONDARY Hypoglycemia |
4; 3 | — |
| SECONDARY Need for NICU Admission |
16; 18 | — |
| SECONDARY Composite |
1; 1 | — |
Summary
Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of c-section in babies born between 32 and 36 weeks to determine if it reduces the risk of hypothermia.
Eligibility Criteria
Inclusion Criteria
- Patients who have non-emergent cesarean deliveries (defined as at least 2 hours prior to planned cesarean)
- Gestational age between 32 weeks and 0 days and 36 weeks and 6 days determined per usual clinical parameters
Exclusion Criteria
- Fetal anomalies or death
- Maternal diabetes
- Neonates with blistering skin conditions
- Reversed end diastolic umbilical artery flow
- Placental abruption
- Chorioamnionitis
- Monochorionic multifetal pregnancies
- Inability to provide consent
- Provider perception that patient is in significant pain and provider perceived contraindications to delayed cord clamping.
Data sourced from ClinicalTrials.gov (NCT04827394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.