High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
2026年7月3日 更新者：Kayseri City Hospital
Heated Humidified High-Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure as Primary Respiratory Support in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trial
This single-center randomized controlled trial compared heated humidified high-flow nasal cannula (HHHFNC) with nasal continuous positive airway pressure (nCPAP) as primary noninvasive respiratory support in preterm infants (gestational age 28-34 weeks; birth weight 1000-2000 g) with moderate respiratory distress syndrome.
The primary outcome was treatment failure requiring invasive mechanical ventilation within the first 7 days.
研究概览
地位
完全的
条件
详细说明
Eighty-six infants were randomized 1:1 to HHHFNC (n=43) or nCPAP (n=43).
Both arms followed identical surfactant, escalation, and weaning protocols.
Outcomes included treatment failure, nasal trauma, sepsis, feeding intolerance, and time to full enteral feeding.
研究类型
介入性
注册 (实际的)
86
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kayseri
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Kayseri、Kayseri、土耳其（türkiye）、38090
- Kayseri City Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
Preterm infants admitted to the NICU who fulfilled all of the following were eligible:
- Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g
- Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS)
- Silverman-Anderson score (SAS) 4 < SAS < 7
- Eligibility for noninvasive ventilatory support
Exclusion Criteria:
- Parental refusal of consent
- Outborn infants transferred from other centers
- Infants who required immediate intubation in the delivery room
- Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects
- Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip)
- Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3)
- Infants who died unexpectedly shortly after admission without respiratory evaluation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1 Heated humidified high-flow nasal cannula (HHHFNC)
n:43 Vapotherm Precision Flow Hi-VNI; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO₂ titrated to SpO₂ 91-95%.
|
HHHFNC delivered via the Vapotherm Precision Flow Hi-VNI system; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO2 titrated to maintain SpO2 91-95%.
其他名称：
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有源比较器：Group 2 Nasal continuous positive airway pressure (nCPAP)
n:43 nCPAP via ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to SpO2 91-95%.
|
nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
大体时间：First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
|
Treatment failure defined as the need for invasive mechanical ventilation per pre-specified criteria (FiO2 >=0.60 to maintain SpO2 91-95%; pH <7.20 with PaCO2 >60 mmHg; recurrent or caffeine-refractory apnea; markedly increased work of breathing; or clinical deterioration determined by the attending neonatologist), assessed at 72 hours, Day 5, and Day 7 of life.
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First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Nasal Trauma
大体时间：During noninvasive respiratory support (first 7 days of life)
|
Nasal trauma defined as redness, excoriation, bleeding, or crusting at the nasal septum or nares attributed to the respiratory support interface.
|
During noninvasive respiratory support (first 7 days of life)
|
|
Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
大体时间：From 72 hours of life through hospital discharge, an average of 24 days
|
Culture-positive late-onset sepsis with onset after 72 hours of life.
|
From 72 hours of life through hospital discharge, an average of 24 days
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Number of Participants With Bronchopulmonary Dysplasia (BPD)
大体时间：At 36 weeks postmenstrual age
|
BPD defined as an oxygen requirement at 36 weeks postmenstrual age.
|
At 36 weeks postmenstrual age
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
大体时间：From randomization through hospital discharge, an average of 24 days
|
PDA requiring medical or surgical treatment.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With Intraventricular Hemorrhage (IVH) of Any Grade
大体时间：From randomization through hospital discharge, an average of 24 days
|
IVH of any grade detected on cranial ultrasound.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With Necrotizing Enterocolitis (NEC) of Any Stage
大体时间：From randomization through hospital discharge, an average of 24 days
|
NEC of any stage.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With Retinopathy of Prematurity (ROP)
大体时间：From randomization through hospital discharge, an average of 24 days
|
ROP of any stage on ophthalmologic examination.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With Periventricular Leukomalacia (PVL)
大体时间：From randomization through hospital discharge, an average of 24 days
|
PVL detected on cranial imaging.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With Feeding Intolerance
大体时间：From randomization through hospital discharge, an average of 24 days
|
Feeding intolerance per pre-specified clinical criteria.
|
From randomization through hospital discharge, an average of 24 days
|
|
Days to Full Enteral Feeding
大体时间：From birth until full enteral feeding is achieved, an average of 8 days
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Number of days from birth to achievement of full enteral feeding (>=120 mL/kg/day).
|
From birth until full enteral feeding is achieved, an average of 8 days
|
|
Duration of Total Parenteral Nutrition (TPN)
大体时间：From birth through hospital discharge, an average of 24 days
|
Total duration of parenteral nutrition, in days.
|
From birth through hospital discharge, an average of 24 days
|
|
Duration of Total Oxygen Support
大体时间：From randomization through hospital discharge, an average of 24 days
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Total duration of any oxygen support, in days.
|
From randomization through hospital discharge, an average of 24 days
|
|
Number of Participants With All-Cause In-Hospital Mortality
大体时间：From randomization through hospital discharge, an average of 24 days
|
All-cause mortality during hospitalization.
|
From randomization through hospital discharge, an average of 24 days
|
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Number of Participants With Air Leak Syndrome
大体时间：First 7 days of life (respiratory support period)
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Air leak syndrome, including pneumothorax.
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First 7 days of life (respiratory support period)
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Number of Participants With Clinically Significant Apnea
大体时间：First 7 days of life (respiratory support period)
|
Clinically significant apnea episodes.
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First 7 days of life (respiratory support period)
|
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Discharge Weight
大体时间：At hospital discharge, an average of 24 days after randomization
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Body weight at hospital discharge, in grams.
|
At hospital discharge, an average of 24 days after randomization
|
|
Hospital Length of Stay
大体时间：From randomization through hospital discharge, an average of 24 days
|
Total length of hospital stay, in days.
|
From randomization through hospital discharge, an average of 24 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.
- Hodgson KA, Wilkinson D, De Paoli AG, Manley BJ. Nasal high flow therapy for primary respiratory support in preterm infants. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006405. doi: 10.1002/14651858.CD006405.pub4.
- Bruet S, Butin M, Dutheil F. Systematic review of high-flow nasal cannula versus continuous positive airway pressure for primary support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):56-59. doi: 10.1136/archdischild-2020-321094. Epub 2021 May 20.
- Luo K, Huang Y, Xiong T, Tang J. High-flow nasal cannula versus continuous positive airway pressure in primary respiratory support for preterm infants: A systematic review and meta-analysis. Front Pediatr. 2022 Nov 21;10:980024. doi: 10.3389/fped.2022.980024. eCollection 2022.
- Aramesh MR, et al. nCPAP vs HFNC for RDS in preterm neonates: a RCT. Curr Respir Med Rev. 2025;21(3). doi:10.2174/011573398X339994241209170750
- Singh S, Ananthan A, Nanavati R. Post-INSURE Administration of Heated Humidified High-Flow Therapy Versus Nasal Continuous Positive Airway Pressure in Preterm Infants More Than 28 Weeks Gestation with Respiratory Distress Syndrome: A Randomized Non-Inferiority Trial. J Trop Pediatr. 2022 Jun 6;68(4):fmac062. doi: 10.1093/tropej/fmac062.
- Demirel G, Vatansever B, Tastekin A. High Flow Nasal Cannula versus Nasal Continuous Positive Airway Pressure for Primary Respiratory Support in Preterm Infants: A Prospective Randomized Study. Am J Perinatol. 2021 Feb;38(3):237-241. doi: 10.1055/s-0039-1696673. Epub 2019 Sep 28.
- Murki S, Singh J, Khant C, Kumar Dash S, Oleti TP, Joy P, Kabra NS. High-Flow Nasal Cannula versus Nasal Continuous Positive Airway Pressure for Primary Respiratory Support in Preterm Infants with Respiratory Distress: A Randomized Controlled Trial. Neonatology. 2018;113(3):235-241. doi: 10.1159/000484400. Epub 2018 Jan 23.
- Lavizzari A, Colnaghi M, Ciuffini F, Veneroni C, Musumeci S, Cortinovis I, Mosca F. Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity: A Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2016 Aug 8. doi: 10.1001/jamapediatrics.2016.1243. Online ahead of print.
- Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年6月1日
初级完成 (实际的)
2022年5月1日
研究完成 (实际的)
2022年5月1日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年7月3日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月3日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Ethics C.D.No:141(Kayseri CH)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The data that support the findings of this study are not publicly available due to privacy and ethical restrictions but are available from the corresponding author upon reasonable request.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.