A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Failure of noninvasive respiratory support
研究概览
简要总结
This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- & Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study.
The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).
详细描述
Parents / Mothers with impending pre-term delivery at <30 weeks of gestation will be approached for informed consent to participate. If consent is given prior to delivery, upon delivery the neonate may be randomly assigned to either Fisher & Paykel CPAP (conventional approach) or Seattle--PAP (experimental approach).
First 72 hours of life: 1) Neonates able to breathe spontaneously on less than 40% oxygen after initial resuscitative efforts and would normally be placed on CPAP will be randomly assigned to one of the two treatment groups using sealed cards generated by a variable block randomization scheme. 2) Neonates requiring increased support after initial resuscitation (intubation, >40% oxygen by CPAP) will not initially be randomized. However, if within the first 72 hours of life, the infant meets NCH criteria for extubation, randomization to CPAP delivery method will be performed. 3) Neonates born at <30 weeks gestation who were intubated at birth and are unable to be weaned from ventilator support will be removed from the study.
72 Hours - 32 Weeks of Life: 1) Neonates from the first period (First 72 Hours of Life, above) who remain on CPAP will continue on randomly assigned CPAP methodology. 2) Neonates from the first period, who failed stabilization on CPAP and required intubation, but are able to be extubated to CPAP will be placed back on their assigned CPAP method. 3) Attempts will be made to wean back to assigned CPAP method any neonates who are >72 hours old and require intubation beyond this period for any reason. 4) If unable to wean back to CPAP prior to 32 weeks of age, these patients will be removed from the study.
CPAP Failure (Sub-Group 1): For the neonates initially assigned to CPAP in the delivery room (sub-group 1), respiratory failure secondary to hyaline membrane disease is recognized as a common occurrence. If a patient assigned to this group, regardless of CPAP methodology, requires a fraction of inspired oxygen (FiO2) greater than 0.40 on CPAP of 6 cm of water (H2O), or is deemed to require intubation for adequate oxygenation, this will be considered a failure of CPAP stabilization. These patients, however, may remain in the study if it becomes clinically feasible to return them back to their assigned CPAP method prior to 72 hours of life. If this is unable to be done, they will be removed from the study.
CPAP Failure (Sub-Group 2): Any neonate that requires FiO2 greater than 0.40 on CPAP of 6 cm H2O or intubation beyond the first 72 hours of life will also be considered CPAP failures. Like those assigned to sub-group 1, these patients may remain in the study if it becomes clinically feasible to return them back to their assigned CPAP method prior to 32 weeks of life. If this is unable to be done, they will be removed from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The nature of this comparative study makes masking device assignment impractical. The objectivity of the outcome assessment will rely upon adherence to formally defined criteria for device support failure.
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure
排除标准
- •Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
- •Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).
结局指标
主要结局
Failure of noninvasive respiratory support
时间窗: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.
The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation. The principal criteria for failure of support are the requirement of an FiO2 greater than 0.40 and CPAP of greater than 6 cm H2O to maintain SaO2 of at least 90%. Support failure also can be declared by the responsible clinician based on best clinical judgment, but any declarations not based on the stated criteria will require written explanations.
次要结局
- pneumothorax(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- nasal trauma(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- retinopathy of prematurity(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- supplemental oxygen requirement(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- ventilation-associated sepsis(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- death of infant(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- Central nervous system (CNS) injury(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
- gastrointestinal complications(After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.)
研究者
Charles Smith
Professor of Pediatrics, Principal Investigator
Seattle Children's Hospital