High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
3. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
86
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kayseri
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Kayseri, Kayseri, Türkei (türkiye), 38090
- Kayseri City Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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%.
Andere Namen:
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Aktiver Komparator: 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%.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Nasal Trauma
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
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Number of Participants With Periventricular Leukomalacia (PVL)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2020
Primärer Abschluss (Tatsächlich)
1. Mai 2022
Studienabschluss (Tatsächlich)
1. Mai 2022
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Juli 2026
Zuerst gepostet (Tatsächlich)
9. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Juli 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Geburtshilfe, Frühgeburt
- Geburtsbedingte Geburtskomplikationen
- Schwangerschaftskomplikationen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Atemstörungen
- Säugling, Frühchen, Krankheiten
- Säugling, Neugeborenes, Krankheiten
- Atemnotsyndrom
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Frühgeburt
- Atemnotsyndrom, Neugeborenes
Andere Studien-ID-Nummern
- Ethics C.D.No:141(Kayseri CH)
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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