Respiratory Distress Syndrome, NewbornNCT07422116
Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates
A study testing Mixsafe T piece resucitator and Standardized T Piece resuscitator in people with Respiratory Distress Syndrome, Newborn and Neonatal Respiratory Disorders, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 weeks and older
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Disorders
- What is being tested?
- Mixsafe T piece resucitator and Standardized T Piece resuscitator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Aug 2024to 21 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates at Cipto Mangunkusumo Hospital
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.
Read the 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.
- Being tested
- Mixsafe T piece resucitator, Standardized T Piece resuscitator
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixsafe T piece resucitatorDevice
Compressor based T piece resuscitator
Standardized T Piece resuscitatorDevice
Standardized T piece resuscitator
| Study group | Role | What they receive |
|---|---|---|
| Mixsafe | Experimental | Mix-safe® (Fyrom) connected to an oxygen source with a maximum total mixed flow of 8 L/minute and Fyrom humidifier. Receives: Device: Mixsafe T piece resucitator |
| Control Group | Active comparator | Neonatal resuscitation using standardized T Piece Resuscitator Receives: Device: Standardized T Piece resuscitator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation at five minute of life
Oxygen saturation (in percentage)
Measured: from birth until the 5th minutes
Secondary outcomes (15)
Time to achieve peripheral oxygen saturation at 80%
Time to achieve peripheral oxygen saturation at 80%
Measured: from birth until oxygen saturation at 80% or until 10 minutes of life, whichever comes first
Heart rate at five minutes of life
Heart rate at five minutes of life
Measured: From birth until five minutes of life
Oxygen fraction at five minutes of life
Oxygen fraction at five minutes of life
Measured: From birth until five minutes of life.
Time to achieve HR > 100x/min
Time to achieve heart rate more than 100 beat per minute.
Measured: From birth until 10 minutes of life
Maximum FiO2
Maximum oxygen fraction during resuscitation
Measured: From birth until 10 minutes of life.
APGAR at five minutes
APGAR score at five minutes of life.
Measured: From birth until five minutes of life
Duration of CPAP
Duration of CPAP used in the delivery room, measured in minutes
Measured: From birth until ten minutes of life
Duration of PPV
Duration of PPV used in the delivery room, measured in minutes
Measured: From birth until ten minutes of life
Intubation
Intubation at delivery room
Measured: From birth until ten minutes of life
Need for surfactant
Administration of surfactant during hospitalization
Measured: From birth until discharged or death, whichever comes first, maximum followed up to 120 days.
Need for methylxanthine
Administration of methylxanthine during hospitalization
Measured: From birth until discharged or death, whichever comes first, followed up to 120 days
Length of stay
Duration of hospitalization among surviving patients
Measured: From birth until dishcarged or followed up to 120 days, whichever comes first
Intraventricular Hemorrhage
Bleeding into the brain's ventricular system in preterm infants, graded I-IV by severity on cranial ultrasound or neuroimaging.
Measured: From birth until death or discharged, whichever comes first, followed up to 120 days
Periventricular Leukomalacia
White matter brain injury near the ventricles due to ischemia or inflammation, associated with later neurodevelopmental impairment. Grading from I to IV on USG or neuroimaging.
Measured: From birth until death, discharged, whichever comes first, followed up to 120 days
Retinopathy of Prematurity
Abnormal retinal vascular development in preterm infants that may progress to retinal detachment and visual impairment if severe. Grade I to IV
Measured: From birth until death or discharged, whichever comes first, followed up to 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Aug 2024
- Primary completion6 Feb 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hardya Gustada Hikmahrachim, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rinawati Rohsiswatmo, Prof., M.D., Ph.D., Principal investigator, Dr Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422116
- Sponsor's protocol ID
- MIXSAFE
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As written in the informed consent that no individual data of participant will be made public
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates at Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT07422116
- Acronym / sponsor ID
- MIXSAFE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixsafe | Experimental | Device: Mixsafe T piece resucitatorMix-safe® (Fyrom) connected to an oxygen source with a maximum total mixed flow of 8 L/minute and Fyrom humidifier. |
| Control Group | Active comparator | Device: Standardized T Piece resuscitatorNeonatal resuscitation using standardized T Piece Resuscitator |
Who may qualify
- Ages
- 25 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixsafe T piece resucitatorCompressor based T piece resuscitator | Device | Mixsafe |
| Standardized T Piece resuscitatorStandardized T piece resuscitator | Device | Control Group |
Primary outcome
Oxygen saturation at five minute of life
Time frame: from birth until the 5th minutes
Oxygen saturation (in percentage)
15 secondary outcomes
Time to achieve peripheral oxygen saturation at 80%
Time frame: from birth until oxygen saturation at 80% or until 10 minutes of life, whichever comes first
Heart rate at five minutes of life
Time frame: From birth until five minutes of life
Oxygen fraction at five minutes of life
Time frame: From birth until five minutes of life.
Time to achieve HR > 100x/min
Time frame: From birth until 10 minutes of life
Maximum FiO2
Time frame: From birth until 10 minutes of life.
APGAR at five minutes
Time frame: From birth until five minutes of life
Duration of CPAP
Time frame: From birth until ten minutes of life
Duration of PPV
Time frame: From birth until ten minutes of life
Intubation
Time frame: From birth until ten minutes of life
Need for surfactant
Time frame: From birth until discharged or death, whichever comes first, maximum followed up to 120 days.
Need for methylxanthine
Time frame: From birth until discharged or death, whichever comes first, followed up to 120 days
Length of stay
Time frame: From birth until dishcarged or followed up to 120 days, whichever comes first
Intraventricular Hemorrhage
Time frame: From birth until death or discharged, whichever comes first, followed up to 120 days
Periventricular Leukomalacia
Time frame: From birth until death, discharged, whichever comes first, followed up to 120 days
Retinopathy of Prematurity
Time frame: From birth until death or discharged, whichever comes first, followed up to 120 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. As written in the informed consent that no individual data of participant will be made public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rinawati Rohsiswatmo, Prof., M.D., Ph.D. principal investigator
Dr Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixsafe T piece resucitator and Standardized T Piece resuscitator in people with Respiratory Distress Syndrome, Newborn and Neonatal Respiratory Disorders, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation at five minute of life (time frame: from birth until the 5th minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.