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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mixsafe | Experimental | Mix-safe® (Fyrom) connected to an oxygen source with a maximum total mixed flow of 8 L/minute and Fyrom humidifier. |
|
| Control Group | Active Comparator | Neonatal resuscitation using standardized T Piece Resuscitator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixsafe T piece resucitator | Device | Compressor based T piece resuscitator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation at five minute of life | Oxygen saturation (in percentage) | from birth until the 5th minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve peripheral oxygen saturation at 80% | Time to achieve peripheral oxygen saturation at 80% | from birth until oxygen saturation at 80% or until 10 minutes of life, whichever comes first |
| Heart rate at five minutes of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rinawati Rohsiswatmo, Prof., M.D., Ph.D. | Dr Cipto Mangunkusumo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
As written in the informed consent that no individual data of participant will be made public
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| Standardized T Piece resuscitator |
| Device |
Standardized T piece resuscitator |
|
Heart rate at five minutes of life
| From birth until five minutes of life |
| Oxygen fraction at five minutes of life | Oxygen fraction at five minutes of life | From birth until five minutes of life. |
| Time to achieve HR > 100x/min | Time to achieve heart rate more than 100 beat per minute. | From birth until 10 minutes of life |
| Maximum FiO2 | Maximum oxygen fraction during resuscitation | From birth until 10 minutes of life. |
| APGAR at five minutes | APGAR score at five minutes of life. | From birth until five minutes of life |
| Duration of CPAP | Duration of CPAP used in the delivery room, measured in minutes | From birth until ten minutes of life |
| Duration of PPV | Duration of PPV used in the delivery room, measured in minutes | From birth until ten minutes of life |
| Intubation | Intubation at delivery room | From birth until ten minutes of life |
| Need for surfactant | Administration of surfactant during hospitalization | From birth until discharged or death, whichever comes first, maximum followed up to 120 days. |
| Need for methylxanthine | Administration of methylxanthine during hospitalization | From birth until discharged or death, whichever comes first, followed up to 120 days |
| Length of stay | Duration of hospitalization among surviving patients | 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. | 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. | 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 | From birth until death or discharged, whichever comes first, followed up to 120 days. |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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