Neonatal Respiratory Disorders, Respiratory Distress Syndrome, Newborn
Conditions
Brief 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.
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.
Interventions
DEVICEMixsafe T piece resucitator
Compressor based T piece resuscitator
DEVICEStandardized T Piece resuscitator
Standardized T piece resuscitator
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Weeks to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation at five minute of life | from birth until the 5th minutes | Oxygen saturation (in percentage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve peripheral oxygen saturation at 80% | from birth until oxygen saturation at 80% or until 10 minutes of life, whichever comes first | Time to achieve peripheral oxygen saturation at 80% |
| Heart rate at five minutes of life | From birth until five minutes of life | Heart rate at five minutes of life |
| Oxygen fraction at five minutes of life | From birth until five minutes of life. | Oxygen fraction at five minutes of life |
| Time to achieve HR > 100x/min | From birth until 10 minutes of life | Time to achieve heart rate more than 100 beat per minute. |
| Maximum FiO2 | From birth until 10 minutes of life. | Maximum oxygen fraction during resuscitation |
| APGAR at five minutes | From birth until five minutes of life | APGAR score at five minutes of life. |
| Duration of CPAP | From birth until ten minutes of life | Duration of CPAP used in the delivery room, measured in minutes |
| Duration of PPV | From birth until ten minutes of life | Duration of PPV used in the delivery room, measured in minutes |
| Intubation | From birth until ten minutes of life | Intubation at delivery room |
| Need for surfactant | From birth until discharged or death, whichever comes first, maximum followed up to 120 days. | Administration of surfactant during hospitalization |
| Need for methylxanthine | From birth until discharged or death, whichever comes first, followed up to 120 days | Administration of methylxanthine during hospitalization |
| Length of stay | From birth until dishcarged or followed up to 120 days, whichever comes first | Duration of hospitalization among surviving patients |
| Intraventricular Hemorrhage | From birth until death or discharged, whichever comes first, followed up to 120 days | Bleeding into the brain's ventricular system in preterm infants, graded I-IV by severity on cranial ultrasound or neuroimaging. |
| Periventricular Leukomalacia | From birth until death, discharged, whichever comes first, followed up to 120 days | 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. |
| Retinopathy of Prematurity | From birth until death or discharged, whichever comes first, followed up to 120 days. | Abnormal retinal vascular development in preterm infants that may progress to retinal detachment and visual impairment if severe. Grade I to IV |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORRinawati Rohsiswatmo, Prof., M.D., Ph.D.
Dr Cipto Mangunkusumo Hospital
Outcome results
None listed