Premature BirthNCT07693530
High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
A study testing Group 1 Heated humidified high-flow nasal cannula (HHHFNC) and Group 2 Nasal continuous positive airway pressure (nCPAP) in people with Premature Birth and Respiratory Distress Syndrome, Newborn, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Premature Birth, Respiratory Distress Syndrome, Newborn
- What is being tested?
- Group 1 Heated humidified high-flow nasal cannula (HHHFNC) and Group 2 Nasal continuous positive airway pressure (nCPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Group 1 Heated humidified high-flow nasal cannula (HHHFNC), Group 2 Nasal continuous positive airway pressure (nCPAP)
- Keywords
- HHHFNC, nCPAP, Preterm infant, Noninvasive respiratory support
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Heated humidified high-flow nasal cannula (HHHFNC)Device
Also called Vapotherm Precision Flow Hi-VNI
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%.
Group 2 Nasal continuous positive airway pressure (nCPAP)Device
Also called nCPAP
nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Device: Group 1 Heated humidified high-flow nasal cannula (HHHFNC) |
| 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%. Receives: Device: Group 2 Nasal continuous positive airway pressure (nCPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
Secondary outcomes (3)
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.
Measured: During noninvasive respiratory support (first 7 days of life)
Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
Culture-positive late-onset sepsis with onset after 72 hours of life.
Measured: 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.
Measured: At 36 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jun 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693530
- Sponsor's protocol ID
- Ethics C.D.No:141(Kayseri CH)
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36863329Hodgson 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.
PubMed 37144837Bruet 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.
PubMed 34016651Luo 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.
PubMed 36479290Aramesh 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.
PubMed 35877150Demirel 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.
PubMed 31563133Murki 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.
PubMed 29393237Lavizzari 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.
PubMed 27532363Roberts 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.
PubMed 27653564
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07693530
- Acronym / sponsor ID
- Ethics C.D.No:141(Kayseri CH)
- Keywords
- HHHFNC, nCPAP, Preterm infant, Noninvasive respiratory support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Heated humidified high-flow nasal cannula (HHHFNC) | Experimental | Device: 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%. |
| Group 2 Nasal continuous positive airway pressure (nCPAP) | Active comparator | Device: 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%. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Heated humidified high-flow nasal cannula (HHHFNC)Also: Vapotherm Precision Flow Hi-VNIHHHFNC 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%. | Device | Group 1 Heated humidified high-flow nasal cannula (HHHFNC) |
| Group 2 Nasal continuous positive airway pressure (nCPAP)Also: nCPAPnCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%. | Device | Group 2 Nasal continuous positive airway pressure (nCPAP) |
Primary outcome
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Time frame: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
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.
3 secondary outcomes
Number of Participants With Nasal Trauma
Time frame: During noninvasive respiratory support (first 7 days of life)
Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
Time frame: From 72 hours of life through hospital discharge, an average of 24 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time frame: At 36 weeks postmenstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 36863329Sweet 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.
- Results publication: PubMed 37144837Hodgson 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.
- Results publication: PubMed 34016651Bruet 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.
- Results publication: PubMed 36479290Luo 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.
- Results publicationAramesh MR, et al. nCPAP vs HFNC for RDS in preterm neonates: a RCT. Curr Respir Med Rev. 2025;21(3). doi:10.2174/011573398X339994241209170750
- Results publication: PubMed 35877150Singh 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.
- Results publication: PubMed 31563133Demirel 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.
- Results publication: PubMed 29393237Murki 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.
- Results publication: PubMed 27532363Lavizzari 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.
- Results publication: PubMed 27653564Roberts 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Heated humidified high-flow nasal cannula (HHHFNC) and Group 2 Nasal continuous positive airway pressure (nCPAP) in people with Premature Birth and Respiratory Distress Syndrome, Newborn, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation (time frame: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693530, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.