Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates at Cipto Mangunkusumo Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Oxygen saturation at five minute of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mixsafe
Mix-safe® (Fyrom) connected to an oxygen source with a maximum total mixed flow of 8 L/minute and Fyrom humidifier.
干预措施: Mixsafe T piece resucitator (Device)
Control Group
Neonatal resuscitation using standardized T Piece Resuscitator
干预措施: Standardized T Piece resuscitator (Device)
结局指标
主要结局
Oxygen saturation at five minute of life
时间窗: from birth until the 5th minutes
Oxygen saturation (in percentage)
次要结局
- Duration of CPAP(From birth until ten minutes of life)
- Duration of PPV(From birth until ten minutes of life)
- Intubation(From birth until ten minutes of life)
- 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(From birth until five minutes of life)
- Oxygen fraction at five minutes of life(From birth until five minutes of life.)
- Time to achieve HR > 100x/min(From birth until 10 minutes of life)
- Maximum FiO2(From birth until 10 minutes of life.)
- APGAR at five minutes(From birth until five minutes of life)
- Need for surfactant(From birth until discharged or death, whichever comes first, maximum followed up to 120 days.)
- Need for methylxanthine(From birth until discharged or death, whichever comes first, followed up to 120 days)
- Length of stay(From birth until dishcarged or followed up to 120 days, whichever comes first)
- Intraventricular Hemorrhage(From birth until death or discharged, whichever comes first, followed up to 120 days)
- Periventricular Leukomalacia(From birth until death, discharged, whichever comes first, followed up to 120 days)
- Retinopathy of Prematurity(From birth until death or discharged, whichever comes first, followed up to 120 days.)
研究者
Hardya Gustada Hikmahrachim
Doctor
Dr Cipto Mangunkusumo General Hospital