ACTRN12622000250730Recruiting未知
Feasibility study of a novel resuscitation monitoring system for measuring mask leak and tidal volumes during neonatal resuscitation
ResusRight Pty Ltd0 sites30 target enrollmentStarted: February 11, 2022Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- Hours to o limit (—)
- Sex
- All
Inclusion Criteria
- •Neonatal participants: There are two groups of neonatal participants for this study.
- •Neonatal Group 1 - Resuscitation at birth
- •Neonates born from 30 weeks gestation that require manual positive pressure ventilation during resuscitation following birth will be recruited to the study.
- •Neonatal Group 2 - Neonatal Intensive Care Neonates
- •Neonates from 26 weeks gestation that are admitted to the NICU that require manual
- •positive pressure ventilation with a facemask during elective/semi-elective endotracheal
- •intubation during their NICU admission.
- •Clinician resuscitators: Medical officers will be eligible to participate if they fulfill all the following criteria:
- •i. Employed at the study site
- •ii. Neonatology Staff Specialist/Neonatal Fellow/neonatal registrar (with minimum 6 months NICU experience)
- •iii. Successfully attend resuscitation training with the NEMO resuscitation monitor.
Exclusion Criteria
- •Neonates will be excluded from the study if they meet the following exclusion criteria:
- •i.Born with a potentially lethal congenital abnormality.
- •ii.Acute, severe, fetal compromise indicating intrapartum still birth (e.g., cessation of fetal heart rate).
- •iii.Unavailability of independent senior resuscitator.
- •iv.Unavailability of research team.
Investigators
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