CompletedNot Applicable

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

Indonesia107 participantsStarted 2024-08-15

Plain-language 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.

Who can participate

Age range25 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Oxygen saturation at five minute of life

Timeframe: from birth until the 5th minutes

Trial details

NCT IDNCT07422116

SponsorDr Cipto Mangunkusumo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-06

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Newborn trials