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临床试验/CTRI/2024/04/065538
CTRI/2024/04/065538尚未招募不适用

Nasal intermittent positive pressure ventilation (NIPPV) versus nasal Continuous positive airway pressure (NCPAP) as a primary respiratory support for preterm infants (≤34 weeks) – A Randomized Control Trial

National Institute of Medical Science and Research Jaipur Rajasthan India1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年4月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
To assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(≤ 34 weeks) with respiratory distress receiving either NIPPV or CPAP.

研究概览

简要总结

Prematurity is associated with respiratory distress due to variable reasons including immature lungs with inadequate surfactant production and relatively weak respiratory muscles with increased lung compliance ultimately leading to atelectasis, poor functional residual capacity, and lung collapse. In the past, preterm infants with signs of moderate or severe respiratory distress were intubated and mechanically ventilated. This invasive approach resulted in inflammation of the lungs in the short term and impaired development and scarring known as bronchopulmonary dysplasia (BPD) in the long term. Efforts to decrease rates of BPD in the surfactant/antenatal steroid era have led to increased use of non-invasive respiratory support for even the most immature infants. Non-invasive ventilation is preferred to use instead of invasive mechanical ventilation. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are the most commonly used non-invasive respiratory support modalities in neonates with respiratory distress compared with others such as high-flow nasal cannula, nasal high-frequency oscillatory ventilation, neutrally adjusted ventilator assist. NCPAP reduces upper airway resistance, helps to establish functional residual capacity, stabilizes the chest wall, and preserves endogenous surfactant. NIPPV was also studied as another method for the RDS treatment. It is a time-cycled pressure-limited ventilation mode, that superimposes an intermittent peak pressure on NCPAP. In addition to the benefits of NCPAP, NIPPV improves ventilation in apnea by providing a backup rate and using sufficient peak inspiratory pressure. Due to the use of higher mean airway pressure, NIPPV results in better alveolar recruitment and improved carbon dioxide clearance.

The majority of clinical trials in preterm infants have compared NIPPV with CPAP as either the primary mode of treatment for neonatal respiratory distress syndrome (RDS), or after extubation. Of these trials, Kirpalani’s NIPPV Trialdominates the literature. This large, pragmatic trial differs from the smaller studies in that it recruited a heterogeneous study population and permitted a variety of devices to deliver NIPPV, including some that delivered synchronized pressure changes. Although pragmatic, the considerable degree of methodological and clinical heterogeneity makes the interpretation of pooled trial results difficult. The primary outcome, death or bronchopulmonary dysplasia (BPD) occurred in 38.4% of randomized neonates on NIPPV and in 36.7% of neonates with CPAP (adjusted odds ratio, 1.09; 95% confidence interval [CI], 0.83–1.43; P5 .56). There were no significant differences between NIPPV and CPAP in the individual components of death or BPD. Majority of clinical trials in preterm infants compared NIPPV with CPAP as a modality after extubation, In this study, we aimed to compare NCPAP vs. NIPPV as an initial treatment of Respiratory distress in terms of prematurity-related morbidities and mortality. This study aim to compare nasal intermittent positive pressure ventilation (NIPPV) versus continuous positive airway pressure (CPAP) as primary respiratory support for preterm infants (≤ 34 weeks) with primary outcome  to assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(≤ 34 weeks) with respiratory distress between NIPPV and CPAP.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • Neonates fulfilling all the following criteria
  • Preterm infants (gestational age ≤ 34 weeks)
  • Respiratory distress, defined as Silverman Andersen Respiratory Severity Score (SAS score ≥3/10)
  • Babies whose parents/Guardians have given informed consent.

排除标准

  • Anyone of the following
  • Major congenital anomaly (antenatally diagnosed or visible at birth)
  • Presence of severe Hemodynamic instability before randomization.
  • [Vasopressor inotrope index ≥ 10 that is dopamine (≥ 10 mcg/kg/min), dobutamine (≥ 10 mcg/kg/min), epinephrine (≥ 0.1 mcg/kg/min), norepinephrine (≥ 0.1 mcg/kg/min), vasopressin (≥ 0.001 IU/kg/min) and milrinone (≥ 0.1 mcg/kg/min)]
  • Baby intubated at or before admission to NICU.

结局指标

主要结局

To assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(≤ 34 weeks) with respiratory distress receiving either NIPPV or CPAP.

时间窗: Discharge from hospital or death

次要结局

  • 1. Need for surfactant(2. Proportion of neonates requiring mechanical ventilation)

研究者

发起方
National Institute of Medical Science and Research Jaipur Rajasthan India
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Gurnoor Singh

National Institute of Medical Science and Research, Jaipur, Rajasthan

研究点 (1)

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