NCT07422116

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

Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates at Cipto Mangunkusumo Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 25 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Delivery and the transition from intrauterine to extrauterine life involve the respiratory transition from the placenta to the lungs. Most neonates breathe spontaneously at birth, but 10% require stimulation, and 1% need positive pressure ventilation. Respiratory disturbances in newborns require proper management because they contribute to high morbidity and mortality rates. The T-piece resuscitator is a commonly used modality for respiratory support. Mix-safe® (Fyrom) is a T-piece resuscitator with an internal compressor developed in Indonesia, offering cost-effective and precise oxygen mixing without the need for compressed air. As of now, there have been no studies examining the non-inferiority status of Mix-safe compared to standard TPR. If proven non-inferior, this device should be distributed across healthcare facilities handling delivery and neonatal resuscitation. This research is a randomized controlled trial, a non-inferiority trial comparing Mix-safe® (treatment group) with NeopuffTM (control group) in providing respiratory assistance during the resuscitation process of newborns. The study is conducted in the Perinatology unit of Cipto Mangunkusumo National Hospital.

Conditions

• Respiratory Distress Syndrome, Newborn
• Neonatal Respiratory Disorders

Interventions

Type	Name	Description
DEVICE	Mixsafe T piece resucitator	Compressor based T piece resuscitator
DEVICE	Standardized T Piece resuscitator	Standardized T piece resuscitator

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-02-06
• Completion: 2025-04-21
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Indonesia