NCT04555889Unknown不适用
The Impact of Lung Recruitment Maneuver in 24-32 Weeks Preterm Babies With Assist-control Volume Guarantee Mode to Their Hemodynamic Status and the Incidence of Bronchopulmonary Dysplasia
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)0 个研究点目标入组 110 人开始时间: 2020年10月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
研究概览
简要总结
hypothesis :
- The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum levels of surfactant protein-D in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The serum concentration of CD-31+ and CD-42b- in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The right and left cardiac output in 24-32 weekers babies on assist-control volume guarantee mode are more higher in lung recruitment maneuver (LRM) group, than group that did not get LRM
- The incident Patent Ductus Arteriosus in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
- The difference tc-pCO2 - PaCO2 , tcO2 index , and strong ion difference (SID) in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control.
详细描述
description of the protocol :
- All Babies that meet inclusion criteria would immediately given surfactan. Babies will do echocardiography, blood gas analize, blood sample, transcutaneous monitor. After that babies will be randomized, the intervention group will get standart protocol + lung recruitment maneuver (LRM) and another group get standart protocol only.
- The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put back 0,2 above closing pressure.
- After 3rd days (72 hours) babies, the investigators will exime serum levels of surfactan protein-D, CD-31+ and CD-42b- , blood gas , tc-pCO2 - PaCO2 , tcO2 index.
- After that babies will observe within 28 days to detect Bronchopulmonary dysplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- All babies wether they experience the intervention ofr not they can not tell to other peoples.
- Only The lab analyzer will be blind to the subject of study, other measurement can not be blind.
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •24-32 weeks preterm babies.
- •Babies on assist-control volume guarantee ventilation with FiO2 > 30% to reach oxygen saturations within 90-95%.
- •Age less than 48 hours.
- •Born in Cipto Mangunkusumo Hospital and Bunda Menteng Hospital.
- •Parents/guardians agreed to participate in this study with sign informed consent.
排除标准
- •Weight birth <750 grams.
- •APGAR score at 10 minutes are <
- •Born with congenital heart disease except patent ductus arteriosus or presistence foramen ovale.
- •Born with congenital disorder that need surgery intervention (for example :
- •diaphragmatic hernia, atresia ani, esophageal atresia, duodenal atresia.
- •Born with congenital disorder that worsening of the respiratory distress (for example
- •hydrops fetalis, phrenic nerve paralysis, abnormality of chest wall, abnormality of air way (for example : Choanal atresia, Laryngeal stenosis, cleft palate.
- •Born inborn error metabolism disease.
研究组 & 干预措施
lung recruitment maneuver (LRM) group
Experimental
The lung recruitment maneuver (LRM) will be done by increasing of PEEP 0,2 cm H2O every 3 minutes, until reach the opening pressure. After that PEEP decrease gradually until get the closing pressure. Than the investigators will back to the opening pressure for 3 minutes, and the final PEEP will be put backo 0,2 above closing pressure.
干预措施: lung recruitment maneuver (LRM) with DrageerVN500 (Device)
without lung recruitment maneuver (LRM) group
No Intervention
Another group get standart protocol only.
结局指标
主要结局
Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with the incidence of Bronchopulmonary dysplasia
时间窗: 12 weeks
Preterm babies ( 24-32 weeks) with Lung Recruitment maneuver will have lower incidence of Bronchopulmonary dysplasia compare to control.
次要结局
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their macro circulation(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their alveolar intergrity (serum levels of surfactan protein-D)(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weekers, with their lung endothel intergrity (serum levels of CD-31+)(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their lung endothel intergrity (serum levels of CD-42b-)(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their micro circulation (oxygen index)(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their their micro circulation (tc-pCO2 - PaCO2 index)(12 weeks)
- Knowing the relationship between lung recruitment maneuver in 24-32 weeks preterm babies with their incidence patent ductus arteriosus (PDA) significant(12 weeks)
研究者
Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
Principal Investigator of Perinatology Division
Dr Cipto Mangunkusumo General Hospital
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