High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
3 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
86
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Kayseri
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Kayseri, Kayseri, Turquia (Türkiye), 38090
- Kayseri City Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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%.
Outros nomes:
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Comparador Ativo: 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%.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Nasal Trauma
Prazo: 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
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: From randomization through hospital discharge, an average of 24 days
|
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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From randomization through hospital discharge, an average of 24 days
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Total length of hospital stay, in days.
|
From randomization through hospital discharge, an average of 24 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2020
Conclusão Primária (Real)
1 de maio de 2022
Conclusão do estudo (Real)
1 de maio de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
16 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de julho de 2026
Primeira postagem (Real)
9 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças urogenitais femininas e complicações na gravidez
- Trabalho de parto prematuro
- Complicações do Trabalho de Parto Obstétrico
- Complicações na Gravidez
- Doenças Respiratórias
- Doenças pulmonares
- Distúrbios Respiratórios
- Lactente, Prematuro, Doenças
- Lactente, Recém Nascido, Doenças
- Síndrome do Desconforto Respiratório
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Nascimento prematuro
- Síndrome do Desconforto Respiratório do Recém-Nascido
Outros números de identificação do estudo
- Ethics C.D.No:141(Kayseri CH)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .