Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates

The aim of the study is to compare the non-inferiority of the Mix-safe T-piece resuscitator (intervention group) to the Neopuff T-piece resuscitator (control group) in providing respiratory assistance during the resuscitation of newborns. If Mix-safe is proven to be non-inferior, the study intends to support its distribution to healthcare facilities that handle delivery and neonatal resuscitation.

NCT Number	NCT07422116
Lead Sponsor	Dr Cipto Mangunkusumo General Hospital
Conditions	Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Disorders
Enrollment	107 participants
Start Date	2024-08-15
Primary Completion	2025-02-06 (estimated)
Study Completion	2025-04-21 (estimated)
Updated on ClinicalTrials.gov	2026-02-19