High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
3 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
86
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Kayseri
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Kayseri, Kayseri, Turquía (Türkiye), 38090
- Kayseri City Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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%.
|
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%.
Otros nombres:
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Comparador activo: 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%.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Nasal Trauma
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
Periodo de tiempo: From randomization through hospital discharge, an average of 24 days
|
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
Periodo de tiempo: From randomization through hospital discharge, an average of 24 days
|
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
Periodo de tiempo: From randomization through hospital discharge, an average of 24 days
|
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)
Periodo de tiempo: 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)
Periodo de tiempo: From randomization through hospital discharge, an average of 24 days
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2020
Finalización primaria (Actual)
1 de mayo de 2022
Finalización del estudio (Actual)
1 de mayo de 2022
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Trabajo de parto prematuro, obstétrico
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Trastornos de la respiración
- Infantil, Prematuro, Enfermedades
- Infantil, Recién Nacido, Enfermedades
- Síndrome de Dificultad Respiratoria
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Nacimiento prematuro
- Síndrome de Dificultad Respiratoria, Recién Nacido
Otros números de identificación del estudio
- Ethics C.D.No:141(Kayseri CH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .