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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
86
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Kayseri
-
Kayseri、Kayseri、トルコ（Türkiye）、38090
- Kayseri City Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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%.
他の名前：
|
|
アクティブコンパレータ：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%.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
時間枠：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.
|
First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Nasal Trauma
時間枠：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
時間枠：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
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
時間枠：At 36 weeks postmenstrual age
|
BPD defined as an oxygen requirement at 36 weeks postmenstrual age.
|
At 36 weeks postmenstrual age
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：From birth until full enteral feeding is achieved, an average of 8 days
|
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)
時間枠：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
時間枠：From randomization through hospital discharge, an average of 24 days
|
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
時間枠：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
|
|
Number of Participants With Air Leak Syndrome
時間枠：First 7 days of life (respiratory support period)
|
Air leak syndrome, including pneumothorax.
|
First 7 days of life (respiratory support period)
|
|
Number of Participants With Clinically Significant Apnea
時間枠：First 7 days of life (respiratory support period)
|
Clinically significant apnea episodes.
|
First 7 days of life (respiratory support period)
|
|
Discharge Weight
時間枠：At hospital discharge, an average of 24 days after randomization
|
Body weight at hospital discharge, in grams.
|
At hospital discharge, an average of 24 days after randomization
|
|
Hospital Length of Stay
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年6月1日
一次修了 (実際)
2022年5月1日
研究の完了 (実際)
2022年5月1日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年7月3日
最初の投稿 (実際)
2026年7月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月9日
QC基準を満たした最後の更新が送信されました
2026年7月3日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Ethics C.D.No:141(Kayseri CH)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。