A first in human study for a new resuscitation monitor for newborn babies requiring resuscitation at birth

Not Applicable

Recruiting

• Conditions: eonates requiring resuscitation with manual positive pressure ventilation following birth.; Neonates requiring resuscitation with manual positive pressure ventilation following birth.; Reproductive Health and Childbirth - Complications of newborn; Emergency medicine - Resuscitation

• Registration Number: ACTRN12622000250730
• Lead Sponsor: ResusRight Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-11
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified