BronchiolitisNCT06621641
Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Intensive Care Unit
A study testing The new HFNC weaning protocol in people with Bronchiolitis and Respiratory Failure (Pediatric Patients), run by Dr. Behcet Uz Children's Hospital at 6 sites in Turkey (Türkiye).
Trial summary
Bronchiolitis is a leading cause of pediatric hospital admissions. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard… Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis, Respiratory Failure (Pediatric Patients), High Flow Nasal Cannula
- What is being tested?
- The new HFNC weaning protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 Jun 2025
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients older than 1 month and younger than 24 months of age; hospitalized at the PICU with the intention of treatment with HFNC at least for the upcoming 4 hours
- Patients with moderate and severe RAS(Respiratory Assessment Scale) requiring HFNC
- Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation
Who cannot join
- İnfants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities.
- Patient with an indication for immediate noninvasive ventilation (NIV)
- Patients deemed at high risk for the need for non-invasive mechanical ventilation within the next 4 hours
- Hemodynamic instability
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Aydin Obstetric and pediatrics Hospital
Aydin, 09020
Erzurum Regional Research and Training Hospital
Erzurum, 25180
Cam Sakura Research and Training Hospital
Istanbul, 34001
Acibadem University, Acibadem Altunizade Hospital
Istanbul
Istanbul Aydin University
Istanbul
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir
About this study
Official title: Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients
Bronchiolitis is a leading cause of pediatric hospital admissions. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing.
Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis.
Read the detailed description
Bronchiolitis is a leading cause of pediatric hospital admissions. While high-flow nasal cannula (HFNC) is effective as a rescue therapy for patients with severe respiratory distress when standard oxygen therapy fails, studies suggest that early use of HFNC in moderate cases does not significantly improve outcomes such as hospital stay duration or intubation rates. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing, raising concerns about unnecessary treatment and extended hospital stays due to a lack of standardized weaning protocols.
Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails, serving as an intermediate step before invasive support. However, the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis. A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale (RAS), with mild, moderate, and severe classifications. The study compares HFNC duration, hospital stay, oxygen support duration, and associated costs before and after the protocol implementation.
Exclusion Criteria:
Premature infants born at less than 32 weeks Patients with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities were excluded.
A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol.
The new HFNC weaning protocol was developed using Quality Improvement (QI) methodology, involving input from pediatricians, nurses, and hospital staff through training sessions. The training lasted one month before the implementation, focusing on classifying patients using the Respiratory Assessment Scale (RAS), which includes respiratory rate, the workload of breathing, and consciousness level. A multidisciplinary team will apply the protocol.
Protocol for Bronchiolitis in Children Under 2 Years:
Aspiration, postural drainage, hydration, antipyretics if necessary, nasal cannula for SpO₂ drop (3-4 L/min)
Despite nasal cannula >3 LPM (FiO₂: 32), hypoxemia (≤92% FiO₂) or moderate-to-severe RAS:
Yes: Start HFNC (High-Flow Nasal Cannula) therapy. No: Continue with HFNC or nasal cannula/mask.
HFNC Therapy Initiation:
Initial FiO₂: 50%, Flow rate: 1-2 L/kg Target SpO₂ between 92-96% by titrating FiO₂. Calculate the baseline ROX index.
Reassess in 30-60 minutes:
Is there clinical deterioration? (Moderate-to-severe RAS)
If clinical deterioration is present:
FiO₂ ≥ 50% SpO₂ < 90% pCO₂ ≥ 60 Positive pressure ventilation should be considered if there is apnea or bradycardia.
If there is no clinical deterioration:
After 4 hours of stable condition, reassess. Is there improvement in RAS and ROX index, and is the patient clinically stable?
Yes:
If FiO₂ < 30%, start weaning the flow rate and FiO₂ simultaneously. Reduce the flow rate by 2 L/min every 2-4 hours, and evaluate the RAS-ROX trend every 2-4 hours.
If there is respiratory deterioration:
Continue or increase HFNC flow rate and FiO₂ as needed.
If there is no respiratory deterioration:
Weaning continues. Discontinue HFNC when the flow rate reaches 4 L/min and FiO₂ < 30%.
Is there respiratory deterioration?
Yes:
Return to the previous flow rate, and reassess within 30 minutes.
Randomization and Groups:
Participants will be randomly assigned to one of two groups:
Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol.
Outcomes:
The 2 groups will be compared regarding HFNC duration, hospital stay, oxygen support duration, intensive care readmission, noninvasive ventilation (NIV) needs, intubation rates, and costs.
- Being tested
- The new HFNC weaning protocol
- Keywords
- bronchiolitis, high flow nasal cannula, Quality Improvement (QI), HFNC protocol
- Medical subject headings
- Bronchiolitis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The new HFNC weaning protocolBehavioural
Patients will be randomly assigned to two groups: one following the new HFNC weaning protocol and another using the standard care protocol. The new protocol includes stepwise flow reduction based on the patient's clinical stability and uses the Respiratory Assessment Scale (RAS) to monitor weaning progress. The protocol emphasizes a multidisciplinary approach involving pediatricians, nurses, and respiratory therapists, with consistent training and application of weaning criteria
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol Group | No intervention | Control Arm (Pre-Protocol Implementation): This group includes patients aged 1-24 months receiving HFNC (High-Flow Nasal Cannula) therapy for bronchiolitis based on the conventional, non-standardized approach. HFNC weaning decisions in this group are made at the treating clinicians' discretion, without following a formal protocol. Decisions are influenced by clinical presentation, respiratory effort, and clinician experience. This group serves as the control arm, representing the current standard of care. |
| New Protocol Group | Active comparator | This group includes patients aged 1-24 months who are randomized to receive HFNC therapy under a newly implemented standardized weaning protocol, developed using Quality Improvement (QI) methodology. The protocol involves a structured, criteria-based weaning approach with clear steps for reducing HFNC support, focusing on clinical indicators like respiratory rate, work of breathing, and oxygen saturation. A multidisciplinary team, including pediatricians, nurses, and respiratory therapists, created this protocol, and staff received training before implementation. Receives: Behavioral: The new HFNC weaning protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFNC duration
HFNC duration calculated during intensive care hospitalization
Measured: Through study completion, an average of 1 year
Hospital length of stay
Total hospital stay time including intensive care unit
Measured: Through study completion, an average of 1 year
Need for non-invasive ventilation
It will be compared whether there is a difference between the two groups in terms of niv needs.
Measured: Through study completion, an average of 1 year
Associated costs
HFNC costs and total hospitalization costs will be calculated
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion30 May 2025
- Study completion30 Jun 2025
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 BronchiolitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol. Participants: Infants aged 1-24 months admitted with bronchiolitis and receiving HFNC therapy will be included. Exclusion criteria include infants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities. Randomization and Groups: Participants will be randomly assigned to one of two groups: Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Medical AG
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
- Investigators
- Hasan Agin, Prof.Dr., Study chair, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621641
- Sponsor's protocol ID
- 02024/GOA-80
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang JX, Colwell B, Vadlaputi P, Sauers-Ford H, Smith BJ, McKnight H, Witkowski J, Padovani A, Aghamohammadi S, Tzimenatos L, Beck Rn S, Reneau K, Nill B, Harbour D, Pegadiotes J, Natale J, Hamline M, Siefkes H. Protocol-Driven Initiation and Weaning of High-Flow Nasal Cannula for Patients With Bronchiolitis: A Quality Improvement Initiative. Pediatr Crit Care Med. 2023 Feb 1;24(2):112-122. doi: 10.1097/PCC.0000000000003136. Epub 2022 Dec 16.
PubMed 36661418Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
PubMed 25349312Kepreotes E, Whitehead B, Attia J, Oldmeadow C, Collison A, Searles A, Goddard B, Hilton J, Lee M, Mattes J. High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial. Lancet. 2017 Mar 4;389(10072):930-939. doi: 10.1016/S0140-6736(17)30061-2. Epub 2017 Feb 2.
PubMed 28161016Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.
PubMed 29562151Collins C, Chan T, Roberts JS, Haaland WL, Wright DR. High-Flow Nasal Cannula in Bronchiolitis: Modeling the Economic Effects of a Ward-Based Protocol. Hosp Pediatr. 2017 Jul 25:hpeds.2016-0167. doi: 10.1542/hpeds.2016-0167. Online ahead of print.
PubMed 28743698Treasure JD, Hubbell B, Statile AM. Enough Is Enough: Quality Improvement to Deimplement High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):e54-e56. doi: 10.1542/hpeds.2021-005849. Epub 2021 Mar 22. No abstract available.
PubMed 33753361Franklin D, Schibler A. Rising Intensive Care Costs in Bronchiolitis Infants-Is Nasal High Flow the Culprit? Pediatr Crit Care Med. 2022 Mar 1;23(3):218-222. doi: 10.1097/PCC.0000000000002900. No abstract available.
PubMed 35238842Charvat C, Jain S, Orenstein EW, Miller L, Edmond M, Sanders R. Quality Initiative to Reduce High-Flow Nasal Cannula Duration and Length of Stay in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):309-318. doi: 10.1542/hpeds.2020-005306. Epub 2021 Mar 22.
PubMed 33753362Peterson RJ, Hassumani DO, Hole AJ, Slaven JE, Tori AJ, Abu-Sultaneh S. Implementation of a High-Flow Nasal Cannula Management Protocol in the Pediatric ICU. Respir Care. 2021 Apr;66(4):591-599. doi: 10.4187/respcare.08284. Epub 2020 Sep 11.
PubMed 32917844Soydan E, Gokpinar EE, Sevinc ZG, Ceylan G, Karakaya O, Albayrak S, Demirel O, Yay ED, Ozdamar NK, Turgut N, Karaarslan U, Agin H. Impact of a nurse-driven high-flow nasal cannula weaning protocol on HFNC duration in infants with bronchiolitis: a randomized controlled trial. Eur J Pediatr. 2026 Mar 23;185(4):201. doi: 10.1007/s00431-026-06875-w.
PubMed 41866402
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients
- ClinicalTrials.gov ID
- NCT06621641
- Acronym / sponsor ID
- 02024/GOA-80
- Keywords
- bronchiolitis, high flow nasal cannula, Quality Improvement (QI), HFNC protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Collaborators
- Hamilton Medical AG
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 Oct 2024 (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.
Bronchiolitis is a leading cause of pediatric hospital admissions. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing.
Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis.
Detailed description
Bronchiolitis is a leading cause of pediatric hospital admissions. While high-flow nasal cannula (HFNC) is effective as a rescue therapy for patients with severe respiratory distress when standard oxygen therapy fails, studies suggest that early use of HFNC in moderate cases does not significantly improve outcomes such as hospital stay duration or intubation rates. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing, raising concerns about unnecessary treatment and extended hospital stays due to a lack of standardized weaning protocols.
Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails, serving as an intermediate step before invasive support. However, the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis. A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale (RAS), with mild, moderate, and severe classifications. The study compares HFNC duration, hospital stay, oxygen support duration, and associated costs before and after the protocol implementation.
Exclusion Criteria:
Premature infants born at less than 32 weeks Patients with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities were excluded.
A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol.
The new HFNC weaning protocol was developed using Quality Improvement (QI) methodology, involving input from pediatricians, nurses, and hospital staff through training sessions. The training lasted one month before the implementation, focusing on classifying patients using the Respiratory Assessment Scale (RAS), which includes respiratory rate, the workload of breathing, and consciousness level. A multidisciplinary team will apply the protocol.
Protocol for Bronchiolitis in Children Under 2 Years:
Aspiration, postural drainage, hydration, antipyretics if necessary, nasal cannula for SpO₂ drop (3-4 L/min)
Despite nasal cannula >3 LPM (FiO₂: 32), hypoxemia (≤92% FiO₂) or moderate-to-severe RAS:
Yes: Start HFNC (High-Flow Nasal Cannula) therapy. No: Continue with HFNC or nasal cannula/mask.
HFNC Therapy Initiation:
Initial FiO₂: 50%, Flow rate: 1-2 L/kg Target SpO₂ between 92-96% by titrating FiO₂. Calculate the baseline ROX index.
Reassess in 30-60 minutes:
Is there clinical deterioration? (Moderate-to-severe RAS)
If clinical deterioration is present:
FiO₂ ≥ 50% SpO₂ < 90% pCO₂ ≥ 60 Positive pressure ventilation should be considered if there is apnea or bradycardia.
If there is no clinical deterioration:
After 4 hours of stable condition, reassess. Is there improvement in RAS and ROX index, and is the patient clinically stable?
Yes:
If FiO₂ < 30%, start weaning the flow rate and FiO₂ simultaneously. Reduce the flow rate by 2 L/min every 2-4 hours, and evaluate the RAS-ROX trend every 2-4 hours.
If there is respiratory deterioration:
Continue or increase HFNC flow rate and FiO₂ as needed.
If there is no respiratory deterioration:
Weaning continues. Discontinue HFNC when the flow rate reaches 4 L/min and FiO₂ < 30%.
Is there respiratory deterioration?
Yes:
Return to the previous flow rate, and reassess within 30 minutes.
Randomization and Groups:
Participants will be randomly assigned to one of two groups:
Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol.
Outcomes:
The 2 groups will be compared regarding HFNC duration, hospital stay, oxygen support duration, intensive care readmission, noninvasive ventilation (NIV) needs, intubation rates, and costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol. Participants: Infants aged 1-24 months admitted with bronchiolitis and receiving HFNC therapy will be included. Exclusion criteria include infants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities. Randomization and Groups: Participants will be randomly assigned to one of two groups: Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol.
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol Group | No intervention | –Control Arm (Pre-Protocol Implementation): This group includes patients aged 1-24 months receiving HFNC (High-Flow Nasal Cannula) therapy for bronchiolitis based on the conventional, non-standardized approach. HFNC weaning decisions in this group are made at the treating clinicians' discretion, without following a formal protocol. Decisions are influenced by clinical presentation, respiratory effort, and clinician experience. This group serves as the control arm, representing the current standard of care. |
| New Protocol Group | Active comparator | Behavioral: The new HFNC weaning protocolThis group includes patients aged 1-24 months who are randomized to receive HFNC therapy under a newly implemented standardized weaning protocol, developed using Quality Improvement (QI) methodology. The protocol involves a structured, criteria-based weaning approach with clear steps for reducing HFNC support, focusing on clinical indicators like respiratory rate, work of breathing, and oxygen saturation. A multidisciplinary team, including pediatricians, nurses, and respiratory therapists, created this protocol, and staff received training before implementation. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients older than 1 month and younger than 24 months of age; hospitalized at the PICU with the intention of treatment with HFNC at least for the upcoming 4 hours
- Patients with moderate and severe RAS(Respiratory Assessment Scale) requiring HFNC
- Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation
Key exclusion criteria (4 listed)
- İnfants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities.
- Patient with an indication for immediate noninvasive ventilation (NIV)
- Patients deemed at high risk for the need for non-invasive mechanical ventilation within the next 4 hours
- Hemodynamic instability
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 |
|---|---|---|
| The new HFNC weaning protocolPatients will be randomly assigned to two groups: one following the new HFNC weaning protocol and another using the standard care protocol. The new protocol includes stepwise flow reduction based on the patient's clinical stability and uses the Respiratory Assessment Scale (RAS) to monitor weaning progress. The protocol emphasizes a multidisciplinary approach involving pediatricians, nurses, and respiratory therapists, with consistent training and application of weaning criteria | Behavioural | New Protocol Group |
Primary outcome
HFNC duration
Time frame: Through study completion, an average of 1 year
HFNC duration calculated during intensive care hospitalization
Hospital length of stay
Time frame: Through study completion, an average of 1 year
Total hospital stay time including intensive care unit
Need for non-invasive ventilation
Time frame: Through study completion, an average of 1 year
It will be compared whether there is a difference between the two groups in terms of niv needs.
Associated costs
Time frame: Through study completion, an average of 1 year
HFNC costs and total hospitalization costs will be calculated
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 25 Nov 2025.
- Background: PubMed 36661418Huang JX, Colwell B, Vadlaputi P, Sauers-Ford H, Smith BJ, McKnight H, Witkowski J, Padovani A, Aghamohammadi S, Tzimenatos L, Beck Rn S, Reneau K, Nill B, Harbour D, Pegadiotes J, Natale J, Hamline M, Siefkes H. Protocol-Driven Initiation and Weaning of High-Flow Nasal Cannula for Patients With Bronchiolitis: A Quality Improvement Initiative. Pediatr Crit Care Med. 2023 Feb 1;24(2):112-122. doi: 10.1097/PCC.0000000000003136. Epub 2022 Dec 16.
- Background: PubMed 25349312Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.
- Background: PubMed 28161016Kepreotes E, Whitehead B, Attia J, Oldmeadow C, Collison A, Searles A, Goddard B, Hilton J, Lee M, Mattes J. High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial. Lancet. 2017 Mar 4;389(10072):930-939. doi: 10.1016/S0140-6736(17)30061-2. Epub 2017 Feb 2.
- Background: PubMed 29562151Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.
- Background: PubMed 28743698Collins C, Chan T, Roberts JS, Haaland WL, Wright DR. High-Flow Nasal Cannula in Bronchiolitis: Modeling the Economic Effects of a Ward-Based Protocol. Hosp Pediatr. 2017 Jul 25:hpeds.2016-0167. doi: 10.1542/hpeds.2016-0167. Online ahead of print.
- Background: PubMed 33753361Treasure JD, Hubbell B, Statile AM. Enough Is Enough: Quality Improvement to Deimplement High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):e54-e56. doi: 10.1542/hpeds.2021-005849. Epub 2021 Mar 22. No abstract available.
- Background: PubMed 35238842Franklin D, Schibler A. Rising Intensive Care Costs in Bronchiolitis Infants-Is Nasal High Flow the Culprit? Pediatr Crit Care Med. 2022 Mar 1;23(3):218-222. doi: 10.1097/PCC.0000000000002900. No abstract available.
- Background: PubMed 33753362Charvat C, Jain S, Orenstein EW, Miller L, Edmond M, Sanders R. Quality Initiative to Reduce High-Flow Nasal Cannula Duration and Length of Stay in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):309-318. doi: 10.1542/hpeds.2020-005306. Epub 2021 Mar 22.
- Background: PubMed 32917844Peterson RJ, Hassumani DO, Hole AJ, Slaven JE, Tori AJ, Abu-Sultaneh S. Implementation of a High-Flow Nasal Cannula Management Protocol in the Pediatric ICU. Respir Care. 2021 Apr;66(4):591-599. doi: 10.4187/respcare.08284. Epub 2020 Sep 11.
- Derived from this study: PubMed 41866402Soydan E, Gokpinar EE, Sevinc ZG, Ceylan G, Karakaya O, Albayrak S, Demirel O, Yay ED, Ozdamar NK, Turgut N, Karaarslan U, Agin H. Impact of a nurse-driven high-flow nasal cannula weaning protocol on HFNC duration in infants with bronchiolitis: a randomized controlled trial. Eur J Pediatr. 2026 Mar 23;185(4):201. doi: 10.1007/s00431-026-06875-w.
- Individual participant dataSharing planned: No
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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.
Hasan Agin, Prof.Dr. study chair
Dr. Behcet Uz Children's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The new HFNC weaning protocol in people with Bronchiolitis and Respiratory Failure (Pediatric Patients), run by Dr. Behcet Uz Children's Hospital at 6 sites 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 3 inclusion and 4 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
HFNC duration (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 NCT06621641, 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 25 Nov 2025.