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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Heated humidified high-flow nasal cannula (HHHFNC) | Experimental | 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%. |
|
| Group 2 Nasal continuous positive airway pressure (nCPAP) | Active Comparator | n:43 nCPAP via ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to SpO2 91-95%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 Heated humidified high-flow nasal cannula (HHHFNC) | Device | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nasal Trauma | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment | 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 |
Inclusion Criteria:
Preterm infants admitted to the NICU who fulfilled all of the following were eligible:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kayseri City Hospital | Kayseri | Kayseri | 38090 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863329 | Result | 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. | |
| 37144837 |
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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.
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|
| Group 2 Nasal continuous positive airway pressure (nCPAP) | Device | nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%. |
|
|
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) | BPD defined as an oxygen requirement at 36 weeks postmenstrual age. | At 36 weeks postmenstrual age |
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 | NEC of any stage. | From randomization through hospital discharge, an average of 24 days |
| Number of Participants With Retinopathy of Prematurity (ROP) | ROP of any stage on ophthalmologic examination. | From randomization through hospital discharge, an average of 24 days |
| Number of Participants With Periventricular Leukomalacia (PVL) | PVL detected on cranial imaging. | From randomization through hospital discharge, an average of 24 days |
| Number of Participants With Feeding Intolerance | Feeding intolerance per pre-specified clinical criteria. | From randomization through hospital discharge, an average of 24 days |
| Days to Full Enteral Feeding | 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) | Total duration of parenteral nutrition, in days. | From birth through hospital discharge, an average of 24 days |
| Duration of Total Oxygen Support | 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 | All-cause mortality during hospitalization. | From randomization through hospital discharge, an average of 24 days |
| Number of Participants With Air Leak Syndrome | Air leak syndrome, including pneumothorax. | First 7 days of life (respiratory support period) |
| Number of Participants With Clinically Significant Apnea | Clinically significant apnea episodes. | First 7 days of life (respiratory support period) |
| Discharge Weight | Body weight at hospital discharge, in grams. | At hospital discharge, an average of 24 days after randomization |
| Hospital Length of Stay | Total length of hospital stay, in days. | From randomization through hospital discharge, an average of 24 days |
| 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. |
| 34016651 | Result | 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. |
| 36479290 | Result | 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. |
| Result | 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 |
| 35877150 | Result | 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. |
| 31563133 | Result | 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. |
| 29393237 | Result | 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. |
| 27532363 | Result | 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. |
| 27653564 | Result | 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. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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