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New breathing device for newborns proves just as effective as current standard

NCT ID NCT07422116

Disease control Sponsor: Dr Cipto Mangunkusumo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new device called Mixsafe works as well as the standard Neopuff device for helping newborns breathe. 107 babies who needed breathing support at birth took part. The goal was to see if Mixsafe could be a safe and effective alternative for hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

107 people

The number who actually took part.

Started

Aug 2024

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal respiratory disorders Respiratory distress syndrome, newborn

Contacts and locations

Locations

  • RSUPN Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.