High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
2026년 7월 3일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
86
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kayseri
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Kayseri, Kayseri, 터키 (Türkiye), 38090
- Kayseri City Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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%.
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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%.
다른 이름들:
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활성 비교기: 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%.
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nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
기간: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Nasal Trauma
기간: During noninvasive respiratory support (first 7 days of life)
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Nasal trauma defined as redness, excoriation, bleeding, or crusting at the nasal septum or nares attributed to the respiratory support interface.
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During noninvasive respiratory support (first 7 days of life)
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Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
기간: From 72 hours of life through hospital discharge, an average of 24 days
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Culture-positive late-onset sepsis with onset after 72 hours of life.
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From 72 hours of life through hospital discharge, an average of 24 days
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Number of Participants With Bronchopulmonary Dysplasia (BPD)
기간: At 36 weeks postmenstrual age
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BPD defined as an oxygen requirement at 36 weeks postmenstrual age.
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At 36 weeks postmenstrual age
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
기간: From randomization through hospital discharge, an average of 24 days
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PDA requiring medical or surgical treatment.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Intraventricular Hemorrhage (IVH) of Any Grade
기간: From randomization through hospital discharge, an average of 24 days
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IVH of any grade detected on cranial ultrasound.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Necrotizing Enterocolitis (NEC) of Any Stage
기간: From randomization through hospital discharge, an average of 24 days
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NEC of any stage.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Retinopathy of Prematurity (ROP)
기간: From randomization through hospital discharge, an average of 24 days
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ROP of any stage on ophthalmologic examination.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Periventricular Leukomalacia (PVL)
기간: From randomization through hospital discharge, an average of 24 days
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PVL detected on cranial imaging.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Feeding Intolerance
기간: From randomization through hospital discharge, an average of 24 days
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Feeding intolerance per pre-specified clinical criteria.
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From randomization through hospital discharge, an average of 24 days
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Days to Full Enteral Feeding
기간: 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).
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From birth until full enteral feeding is achieved, an average of 8 days
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Duration of Total Parenteral Nutrition (TPN)
기간: From birth through hospital discharge, an average of 24 days
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Total duration of parenteral nutrition, in days.
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From birth through hospital discharge, an average of 24 days
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Duration of Total Oxygen Support
기간: From randomization through hospital discharge, an average of 24 days
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Total duration of any oxygen support, in days.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With All-Cause In-Hospital Mortality
기간: From randomization through hospital discharge, an average of 24 days
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All-cause mortality during hospitalization.
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From randomization through hospital discharge, an average of 24 days
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Number of Participants With Air Leak Syndrome
기간: 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
기간: First 7 days of life (respiratory support period)
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Clinically significant apnea episodes.
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First 7 days of life (respiratory support period)
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Discharge Weight
기간: At hospital discharge, an average of 24 days after randomization
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Body weight at hospital discharge, in grams.
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At hospital discharge, an average of 24 days after randomization
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Hospital Length of Stay
기간: From randomization through hospital discharge, an average of 24 days
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Total length of hospital stay, in days.
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From randomization through hospital discharge, an average of 24 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 6월 1일
기본 완료 (실제)
2022년 5월 1일
연구 완료 (실제)
2022년 5월 1일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 7월 3일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Ethics C.D.No:141(Kayseri CH)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .