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

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.

Inclusion criteria

• Neonates who require respiratory assistance, either VTP or CPAP, according to the IDAI 2022 neonatal resuscitation guidelines.
• Parents/guardians agree to participate in the study.

Exclusion criteria

• Neonates with congenital malformations that interfere with respiration: cleft lip and palate, choanal atresia, Pierre-Robin syndrome, cystic hygroma, facial region tumors, congenital diaphragmatic hernia.
• Neonates with congenital metabolic disorders.
• Neonates suspected of having a syndrome or genetic disorder.
• Neonates with pulmonary hypoplasia.
• Gestational age < 25 weeks.
• Birth weight < 500 g.
• Known to have congenital heart defects through fetomaternal ultrasound examination.
• Parents/guardians do not agree to participate in the study.