Effectiveness of Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Post Extubation Respiratory Support in Neonates Born At ≥ 26 Weeks' Gestation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Extubation Failure Within 72 Hours
研究概览
简要总结
The goal of this clinical trial is to learn which breathing support works better after removing a newborn's breathing tube. Researchers will study newborns born at 26 weeks of gestation or later. Each newborn will have received breathing support through a tube for at least 24 hours.
The main questions it aims to answer are:
Does noninvasive high-frequency oscillatory ventilation (nHFOV) lower the need to replace the breathing tube within 72 hours? What breathing, feeding, or other medical problems occur with each type of support?
Researchers will compare nHFOV with nasal intermittent mandatory ventilation (NIMV). nHFOV provides very rapid pressure waves through the nose. NIMV provides regular, timed breaths through the nose. The researchers will compare these methods to see which works better after breathing tube removal.
Participants will:
Be assigned by chance to receive either nHFOV or NIMV Receive the assigned breathing support immediately after tube removal Have their breathing, oxygen level, and general condition closely monitored Have blood tests at 1, 12, and 24 hours post extubation to assess their breathing Be monitored for breathing pauses, feeding problems, and other medical problems during hospitalization
详细描述
Extubation failure, defined as the need to replace an endotracheal breathing tube after planned removal, is associated with longer hospitalization and increased illness and death in newborns. Noninvasive respiratory support may help newborns transition safely from invasive mechanical ventilation. Nasal intermittent mandatory ventilation (NIMV) delivers regular positive pressure breaths through a nasal interface. Noninvasive high frequency oscillatory ventilation (nHFOV) delivers rapid pressure oscillations through a nasal interface and may improve carbon dioxide removal without requiring synchronization with the newborn's breathing. Although both methods are used in neonatal care, evidence directly comparing them in Pakistan is limited.
NOV-A is a prospective, single center, open label, parallel group superiority randomized clinical trial. It will evaluate whether nHFOV lowers extubation failure compared with NIMV after the first planned extubation. Participants will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. An independent biostatistician will generate the allocation sequence. Allocation will remain concealed in sequentially numbered, opaque, sealed envelopes until eligibility and parental consent are confirmed.
Blinding of the treating clinicians is not possible because the two respiratory support methods use different ventilator settings. To limit bias, prespecified clinical and laboratory criteria will guide decisions to replace the breathing tube. The biostatistician will remain unaware of group identities until the primary analysis is complete.
The primary analysis will follow the intention to treat principle. The treatment effect will be reported as the difference between the proportions of participants requiring replacement of the breathing tube, with a two sided 95% confidence interval. A per protocol analysis will be conducted as a sensitivity analysis. An independent Data Safety Monitoring Board will review safety information after approximately 25%, 50%, and 75% of planned enrollment.
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 independent biostatistician conducting the primary analysis will be masked to the intervention identities. The study groups will be coded as Group A and Group B until the primary analysis is completed.
This explains why the trial is registered as open-label while the statistical analysis remains masked.
入排标准
- 年龄范围
- 1 Day 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth ≥26 weeks (inborn or outborn)
- •Postmenstrual age <44 weeks at enrollment according to NICU AKUH admission criteria
- •Intubation for respiratory distress or respiratory failure
- •Intubated for ≥24 hours
- •Undergoing first planned extubation
- •Meets prespecified extubation readiness criteria
- •Written informed consent from a parent or legal guardian
排除标准
- •Birth weight <500 g
- •Major congenital anomaly affecting cardiac or respiratory function
- •Upper airway anomaly
- •Neuromuscular disorder affecting respiration
- •Requirement for surgical intervention during the study period
- •Grade IV intraventricular hemorrhage diagnosed before randomization
- •Intubation solely for an elective procedure in an otherwise healthy neonate previously breathing room air
研究组 & 干预措施
Noninvasive High Frequency Oscillatory Ventilation (nHFOV)
Participants assigned to this arm will receive noninvasive high frequency oscillatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O, amplitude will be 15-25 cm H₂O, frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Settings may be adjusted according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%.
干预措施: Noninvasive High Frequency Oscillatory Ventilation (Device)
Nasal Intermittent Mandatory Ventilation (NIMV)
Participants assigned to this arm will receive nasal intermittent mandatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, peak inspiratory pressure will be 18-24 cm H₂O, the initial breathing rate will be 30 breaths per minute, and inspiratory time will be 0.5 seconds. The breathing rate may be increased in steps of 5 to a maximum of 50 breaths per minute according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used.
干预措施: Nasal Intermittent Mandatory Ventilation (Device)
结局指标
主要结局
Proportion of Participants With Extubation Failure Within 72 Hours
时间窗: Within 72 hours after planned extubation
Extubation failure is defined as reintubation and return to invasive mechanical ventilation within 72 hours after planned extubation. Reintubation will be based on at least one prespecified criterion: pH below 7.20 with carbon dioxide above 65 mmHg, need for 60% or more oxygen to maintain the target oxygen saturation, an episode requiring bag mask ventilation, severe respiratory distress or a Silverman Anderson score of 7 or higher or cardiorespiratory arrest requiring cardiopulmonary resuscitation. The outcome will be reported as the number and percentage of participants with extubation failure in each group.
次要结局
- Proportion of Participants With Clinically Significant Apnea(Within 72 hours after planned extubation)
- Proportion of Participants With Feeding Intolerance(Within 72 hours after planned extubation)
- Post-extubation blood pH(At 1, 12, and 24 hours after planned extubation)
- Post-extubation partial pressure of carbon dioxide(At 1, 12, and 24 hours after planned extubation)
- Post-extubation SpO₂/FiO₂ ratio(At 1, 12, and 24 hours after planned extubation)
研究者
Ali S. Hussain
Assistant Professor of Paediatrics
Aga Khan University