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临床试验/NCT06737003
NCT06737003已完成不适用

Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Evaluate the efficacy of NHFOV and Hi-VNI Vapotherm in comparison to nasal CPAP as a primary noninvasive respiratory support in preterm neonates

研究概览

简要总结

to evaluate the efficacy of Nasal high frequency oscillatory ventilation (NHFOV) and Vapotherm in comparison to nasal Continuous positive airway pressure (CPAP) as a primary noninvasive respiratory support in preterm neonates

详细描述

  • A randomized controlled trial was conducted in the period from September 2021 to September 2022 in a tertiary -level Neonatal Intensive Care Unit (NICU) , Childrens' Hospital, Ain Shams University, Cairo, Egypt. The study was approved by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University; ID: FMASU 179/2021.
  • This study included spontaneously breathing preterm neonates with gestational age equal to or less than 35 weeks in need for noninvasive respiratory support during their first 3 days of life for primary treatment of respiration distress syndrome.
  • Diagnosis of Respiratory distress syndrome (RDS) was done by clinical examination, including signs of respiratory distress, venous blood gases showing hypoxemia and hypercapnia, and chest X-ray showing diffuse atelectasis, classically described as a ground glass appearance .
  • Neonates with upper or lower airway anomalies or significant congenital anomalies were excluded from the study.
  • Out of 105 neonates assessed for eligibility, 15 were excluded; 10 guardians declined to participate, and 5 didn't meet the inclusion criteria. Thus, 90 neonates were enrolled.

Out of 105 preterm neonates assessed for eligibility, 15 neonates were excluded: 3 had confirmed congenital heart disease, 2 had cleft palate, and 10 parents/guardians refused to consent . 90 neonates were randomly allocated to the three noninvasive modes using a computer-based randomization program, with 30 neonates in each group. Sealed envelopes containing treatment assignments were opened in a sequential manner. No crossover was allowed in the study.

NHFOV group: was delivered by SLE 6000 device (Wipro GE Healthcare Private Limited, Bengaluru, Karnataka). Settings: amplitude range (20:35) cm H2O, frequency range (8-12) HZ, Mean airway pressure (MAP) range (6:10) cm H2O, and Inspiration :Expiration (I:E) ratio 1:1 to 1:2 in case of air trapping, using nasal prongs .

Vapotherm Group: was delivered by Vapotherm Device (Vapotherm, INC, USA). Settings: flow rate 4-6 L/min, with temperature 36-37 °C and Fraction of inspired oxygen(FiO2) titrated as needed to achieve target Saturation of peripheral oxygen (SpO2) (90% to 94%) using soft nasal cannula interface .

Nasal CPAP Group: was delivered by MEDIN CNO device (Medin Medical Innovations GmbH, Olching, Germany). Settings: pressure ranging from 5 to 8 cm H2O to maintain SpO2 from 90% to 94% using bi-nasal prongs.

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
Single (Participant)

入排标准

年龄范围
25 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Preterm neonates with gestational age ≤ 35 weeks with RDS that need noninvasive ventilatory support primarily.

排除标准

  • •Patients with major upper or lower airway anomalies.
  • •Patients with significant congenital anomalies including cardiac, abdominal or respiratory.

研究组 & 干预措施

NHFOV group

Active Comparator

Nasal high frequency oscillatory ventilation (NHFOV) will be delivered by; SLE 6000 device, Wipro GE Healthcare Private Limited, Bengaluru, Karnataka. Amplitude range (20:35), frequency range (8-12)HZ, Mean air way pressure(MAP) range (6: 10) cmH2O and Inspiration :Expiration (I:E) ratio 1:1 may change to 1:2 in case of air trapping .

干预措施: Nasal high frequency oscillatory ventilation (Device)

Vapotherm group

Active Comparator

Vapotherm will be delivered by; Vapotherm device,Vapotherm,INC,USA. The recommended starting flow rate is 4-6 L/min. To be titrated to clinical effect to maximum of 8 L/min as needed,with temperature 36-37°C andFraction of inspired oxygen (FiO2) titrated as needed to achieve target Saturation of peripheral oxygen (SpO2)(90% to 94%).

干预措施: Vapotherm Group (Device)

Standard noninvasive mechanical ventilation group (CPAP)

Active Comparator

CPAP will be delivered by; MEDIN CNO device, medin Medical Innovations GmbH, Olching, Germany . Pressure ranging from 5 to 8 cm H2O,to maintain SpO2 from 90% to 94%.

干预措施: Nasal CPAP Group (Device)

结局指标

主要结局

Evaluate the efficacy of NHFOV and Hi-VNI Vapotherm in comparison to nasal CPAP as a primary noninvasive respiratory support in preterm neonates

时间窗: 1year

By Assessment of the need for invasive mechanical ventilation (IMV) during the first 72 hours after enrollment in one of the groups.

次要结局

  • Assessment of right ventricular output (RVO)in ml/kg/min, left ventricular output (LVO) in ml/kg/min, and superior vena cava (SVC) flow in ml/kg/min,one hour before and one hour after discontinuation of noninvasive respiratory support.(1 year)
  • Assessment of cerebral blood flow in ml/kg/min ,one hour before and one hour after discontinuation of noninvasive respiratory support.(1 year)
  • Assessment of pre-prandial superior mesenteric artery (SMA) velocity and volume of flow in ml/kg/min ,one hour before and one hour after discontinuation of noninvasive respiratory support.(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Ali El-Farrash

Professor of Pediatrics

Ain Shams University

研究点 (1)

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