N/A
Completed N=42
Time to Accurate Heart Rate on Neonatal Outcomes
Premature Infant · Extremely Low Birth Weight · Extreme Prematurity
Source: ClinicalTrials.gov NCT04587934 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Time to Heart Rate Display in iRes Warmer With Resusview — 16; 50 seconds from time of birth
Summary
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Heart Rate Display in iRes Warmer With Resusview |
16; 50 | — |
| SECONDARY Time to First Change in Fraction of Inspired Oxygen |
160; 175 | — |
| SECONDARY Time to First Change in Airway Pressure |
215; 100 | — |
| SECONDARY Time to Initiation of Positive Pressure Ventilation (PPV) |
58; 139 | — |
Eligibility Criteria
Inclusion Criteria
- Infants who are delivered to mothers over the age of 16 years of age
- Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.
- Infants without known congenital malformations prior to delivery
- Antenatal consent
Exclusion Criteria
- Infants who are delivered to mothers under the age of 16 years of age
- Known congenital anomalies of newborn prior to delivery
- Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus
- Multiples
- Declined consent
- iRes Warmer with ResusView not available at time of delivery
Data sourced from ClinicalTrials.gov (NCT04587934). 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. Informational only — not medical advice.