Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Primary Respiratory Support in Preterm Neonates With Respiratory Distress Syndrome: A Non Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Proportion of preterm neonates with treatment failure requiring invasive mechanical ventilation
研究概览
简要总结
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe.
The main questions it aims to answer are:
Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support?
Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital.
Babies will:
Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required
The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.
详细描述
Direct comparisons of nasal high frequency oscillatory ventilation (nHFOV) and nasal intermittent mandatory ventilation (NIMV) as primary respiratory support for preterm neonates with respiratory distress syndrome are limited, particularly in Pakistan and other lower middle income settings. Both methods are routinely used at Aga Khan University Hospital, but the choice between them currently depends mainly on the treating clinician's preference. This study is intended to provide local evidence that may guide a more standardized approach to early noninvasive respiratory support.
This is a prospective, single center, open label, parallel group, non inferiority randomized controlled trial. A total of 158 neonates will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent biostatistician. Because the two ventilation modes use visibly different settings, treating clinicians and research personnel will not be blinded. Statistical analysis will remain blinded until completion of the primary analysis.
The primary analysis will estimate the risk difference in treatment failure between the nHFOV and NIMV groups with a two-sided 95% confidence interval. nHFOV will be considered non-inferior if the upper limit of the confidence interval is below the prespecified absolute non-inferiority margin of 15 percentage points. Both intention to treat and per protocol analyses will be performed. An independent Data and Safety Monitoring Board will review safety data 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 statistical analysis will be performed using treatment groups coded as Group A and Group B. The statistician will remain masked to the identity of the assigned interventions until the primary analysis is completed.
入排标准
- 年龄范围
- 0 Hours 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates born between 28+0 and 36+0 weeks of gestation, whether inborn or outborn
- •Gestational age confirmed by first-trimester ultrasound, last menstrual period, or Ballard score
- •Clinical and radiological evidence of respiratory distress syndrome
- •Requirement for NIMV-level noninvasive respiratory support according to the protocol-defined criteria
- •Enrollment and randomization within 6 hours after birth
- •Written informed consent provided by a parent or legal guardian
排除标准
- •Intubation and receipt of invasive mechanical ventilation at the time of enrollment
- •Receipt of surfactant before randomization by any method, including INSURE, LISA, MIST, or surfactant administration before transfer to Aga Khan University Hospital
- •Major congenital anomaly affecting respiratory or cardiovascular physiology
研究组 & 干预措施
Nasal High-Frequency Oscillatory Ventilation (nHFOV)
Preterm neonates randomized to this arm will receive nasal high frequency oscillatory ventilation (nHFOV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
干预措施: Noninvasive High Frequency Oscillatory Ventilation (Device)
Nasal Intermittent Mandatory Ventilation (NIMV)
Preterm neonates randomized to this arm will receive nasal intermittent mandatory ventilation (NIMV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. Settings, including FiO₂, will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
干预措施: Nasal Intermittent Mandatory Ventilation (Device)
结局指标
主要结局
Proportion of preterm neonates with treatment failure requiring invasive mechanical ventilation
时间窗: Within 72 hours after randomization
Treatment failure is defined as initiation of invasive mechanical ventilation due to any of the following: pH \<7.20 with pCO₂ \>60 mmHg on two blood gas measurements at least 30 minutes apart, SpO₂ \<90% with FiO₂ \>0.60 for at least 15 minutes on maximal noninvasive support; at least one apnea episode requiring bag mask ventilation; Silverman Anderson Score ≥7 on maximal noninvasive support; hemodynamic instability requiring inotropic support secondary to respiratory failure, or the physician's decision to intubate for clinical reasons with written justification. The number and proportion of neonates meeting the treatment failure criteria will be reported in each study arm.
次要结局
- Proportion of Eligible Neonates With Bronchopulmonary Dysplasia at 36 Weeks' Postmenstrual Age Description(At 36 weeks' postmenstrual age)
- Proportion of eligible neonates with severe intraventricular hemorrhage(From randomization until 44 weeks' postmenstrual age or final hospital disposition, whichever occurs first)
- Proportion of Eligible Neonates With Treatment-Requiring Retinopathy of Prematurity(From the first ROP screening examination until 44 weeks' postmenstrual age or discharge from ROP screening by the treating ophthalmologist, whichever occurs first)
研究者
Ali S. Hussain
Assistant Professor of Paediatrics
Aga Khan University