Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates (NCT07422116) | Clinical Trial Compass
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 range
25 Weeks
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.