Extubation Failure in NeonatesNOV-ANCT07836166
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation After Extubation in Neonates
A study testing Noninvasive High Frequency Oscillatory Ventilation and Nasal Intermittent Mandatory Ventilation in people with Extubation Failure in Neonates, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn which breathing support works better after removing a newborn's breathing tube. Researchers will study newborns born at 26 weeks of gestation or later. Each newborn will have received breathing support through a tube for at least 24 hours. Read more about this study
- Who is it for?
- Ages 1 day to 18 weeks
- Conditions the study is for
- Extubation Failure in Neonates
- What is being tested?
- Noninvasive High Frequency Oscillatory Ventilation and Nasal Intermittent Mandatory Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to 21 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth ≥26 weeks (inborn or outborn)
- Postmenstrual age <44 weeks at enrollment according to NICU AKUH admission criteria
- Intubation for respiratory distress or respiratory failure
- Intubated for ≥24 hours
- Undergoing first planned extubation
- Meets prespecified extubation readiness criteria
- Written informed consent from a parent or legal guardian
Who cannot join
- Birth weight <500 g
- Major congenital anomaly affecting cardiac or respiratory function
- Upper airway anomaly
- Neuromuscular disorder affecting respiration
- Requirement for surgical intervention during the study period
- Grade IV intraventricular hemorrhage diagnosed before randomization
- Intubation solely for an elective procedure in an otherwise healthy neonate previously breathing room air
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan
Karachi, Sindh, 74800
Hafsah Naz, Fellow Paediatric Neonatology, 03310478376 ext. 3390, hafsah.naz@aku.edu
About this study
Official title: Effectiveness of Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Post Extubation Respiratory Support in Neonates Born At ≥ 26 Weeks' Gestation: A Randomized Clinical Trial
The goal of this clinical trial is to learn which breathing support works better after removing a newborn's breathing tube. Researchers will study newborns born at 26 weeks of gestation or later. Each newborn will have received breathing support through a tube for at least 24 hours.
The main questions it aims to answer are:
Read more
Does noninvasive high-frequency oscillatory ventilation (nHFOV) lower the need to replace the breathing tube within 72 hours? What breathing, feeding, or other medical problems occur with each type of support?
Researchers will compare nHFOV with nasal intermittent mandatory ventilation (NIMV). nHFOV provides very rapid pressure waves through the nose. NIMV provides regular, timed breaths through the nose. The researchers will compare these methods to see which works better after breathing tube removal.
Participants will:
Be assigned by chance to receive either nHFOV or NIMV Receive the assigned breathing support immediately after tube removal Have their breathing, oxygen level, and general condition closely monitored Have blood tests at 1, 12, and 24 hours post extubation to assess their breathing Be monitored for breathing pauses, feeding problems, and other medical problems during hospitalization
Read the detailed description
Extubation failure, defined as the need to replace an endotracheal breathing tube after planned removal, is associated with longer hospitalization and increased illness and death in newborns. Noninvasive respiratory support may help newborns transition safely from invasive mechanical ventilation. Nasal intermittent mandatory ventilation (NIMV) delivers regular positive pressure breaths through a nasal interface. Noninvasive high frequency oscillatory ventilation (nHFOV) delivers rapid pressure oscillations through a nasal interface and may improve carbon dioxide removal without requiring synchronization with the newborn's breathing. Although both methods are used in neonatal care, evidence directly comparing them in Pakistan is limited.
NOV-A is a prospective, single center, open label, parallel group superiority randomized clinical trial. It will evaluate whether nHFOV lowers extubation failure compared with NIMV after the first planned extubation. Participants will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. An independent biostatistician will generate the allocation sequence. Allocation will remain concealed in sequentially numbered, opaque, sealed envelopes until eligibility and parental consent are confirmed.
Blinding of the treating clinicians is not possible because the two respiratory support methods use different ventilator settings. To limit bias, prespecified clinical and laboratory criteria will guide decisions to replace the breathing tube. The biostatistician will remain unaware of group identities until the primary analysis is complete.
The primary analysis will follow the intention to treat principle. The treatment effect will be reported as the difference between the proportions of participants requiring replacement of the breathing tube, with a two sided 95% confidence interval. A per protocol analysis will be conducted as a sensitivity analysis. An independent Data Safety Monitoring Board will review safety information after approximately 25%, 50%, and 75% of planned enrollment.
- Conditions
- Extubation Failure in Neonates
- Being tested
- Noninvasive High Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive High Frequency Oscillatory VentilationDevice
Also called nHFOV, Nasal High Frequency Oscillatory Ventilation
nHFOV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O and may be increased in 1 cm H₂O steps to a maximum of 20 cm H₂O. Initial amplitude will be 15-25 cm H₂O and may be increased in 5 cm H₂O steps to a maximum of 35 cm H₂O. Frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Settings will be adjusted according to the participant's clinical condition.
Nasal Intermittent Mandatory VentilationDevice
Also called NIMV, Nasal Intermittent Positive Pressure Ventilation, NIPPV
NIMV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, and peak inspiratory pressure will be 18-24 cm H₂O. The initial breathing rate will be 30 breaths per minute and may be increased in steps of 5 to a maximum of 50 breaths per minute according to carbon dioxide levels and clinical assessment. Inspiratory time will be 0.5 seconds. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive High Frequency Oscillatory Ventilation (nHFOV) | Experimental | Participants assigned to this arm will receive noninvasive high frequency oscillatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O, amplitude will be 15-25 cm H₂O, frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Settings may be adjusted according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Receives: Device: Noninvasive High Frequency Oscillatory Ventilation |
| Nasal Intermittent Mandatory Ventilation (NIMV) | Active comparator | Participants assigned to this arm will receive nasal intermittent mandatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, peak inspiratory pressure will be 18-24 cm H₂O, the initial breathing rate will be 30 breaths per minute, and inspiratory time will be 0.5 seconds. The breathing rate may be increased in steps of 5 to a maximum of 50 breaths per minute according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used. Receives: Device: Nasal Intermittent Mandatory Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Extubation Failure Within 72 Hours
Extubation failure is defined as reintubation and return to invasive mechanical ventilation within 72 hours after planned extubation. Reintubation will be based on at least one prespecified criterion: pH below 7.20 with carbon dioxide above 65 mmHg, need for 60% or more oxygen to maintain the target oxygen saturation, an episode requiring bag mask ventilation, severe respiratory distress or a Silverman Anderson score of 7 or higher or cardiorespiratory arrest requiring cardiopulmonary resuscitation. The outcome will be reported as the number and percentage of participants with extubation failure in each group.
Measured: Within 72 hours after planned extubation
Secondary outcomes (5)
Proportion of Participants With Clinically Significant Apnea
Clinically significant apnea is defined as three or more breathing pauses within 72 hours after planned extubation that require tactile stimulation. The outcome will be reported as the number and percentage of participants meeting this criterion in each group.
Measured: Within 72 hours after planned extubation
Proportion of Participants With Feeding Intolerance
Feeding intolerance is defined as two consecutive gastric residual volumes greater than 50% of the previous feed volume, abdominal distension or vomiting that requires enteral feeding to be interrupted or modified for more than 24 hours while the participant is receiving the assigned respiratory support. The outcome will be reported as the number and percentage of participants with feeding intolerance in each group.
Measured: Within 72 hours after planned extubation
Post-extubation blood pH
Blood pH measured using an arterial or capillary blood gas sample. Values will be recorded and reported separately at 1, 12, and 24 hours after planned extubation. This is a component of the prespecified secondary outcome assessing post-extubation gas exchange and oxygenation.
Measured: At 1, 12, and 24 hours after planned extubation
Post-extubation partial pressure of carbon dioxide
Partial pressure of carbon dioxide (pCO₂), measured in mmHg using an arterial or capillary blood gas sample. Values will be recorded and reported separately at 1, 12, and 24 hours after planned extubation. This is a component of the prespecified secondary outcome assessing post-extubation gas exchange and oxygenation.
Measured: At 1, 12, and 24 hours after planned extubation
Post-extubation SpO₂/FiO₂ ratio
The ratio of peripheral oxygen saturation (SpO₂) to the fraction of inspired oxygen (FiO₂). The ratio is unitless. Values will be recorded and reported separately at 1, 12, and 24 hours after planned extubation. This is a component of the prespecified secondary outcome assessing post-extubation gas exchange and oxygenation.
Measured: At 1, 12, and 24 hours after planned extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion3 Oct 2028 (estimated)
- Study completion21 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extubation Failure in NeonatesStudies 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
- Model description
- This is a two arm, parallel group, open-label superiority trial. Participants will be randomly assigned in a 1:1 ratio to receive either noninvasive high frequency oscillatory ventilation or nasal intermittent mandatory ventilation immediately after planned extubation. Randomization will use permuted blocks within three gestational age groups: 26 to 31 weeks and 6 days, 32 to 36 weeks and 6 days, and 37 weeks or later. Each participant will remain in the assigned group for the study intervention.
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali S. Hussain, Aga Khan University
- Investigators
- Ali S Hussain, FCPS Paediatrics, Neonatology, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836166
- Sponsor's protocol ID
- 13559
- Acronym
- NOV-A
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data with external researchers. Participants are newborn infants, and the study will collect sensitive clinical information. The consent and data protection procedures do not provide for unrestricted public release of participant level data. Study findings will be reported in aggregate form through scientific presentations, trial registries, and peer-reviewed publications. Any future request for de-identified participant data would require review and approval by the study investigators, Aga Khan University Ethics Review Committee, and relevant institutional data governance authorities.
Publications
Mei Z, Ming L, Wu Z, Zhu Y. Use of NHFOV vs. NIPPV for the respiratory support of preterm newborns after extubation: A meta-analysis. Front Pediatr. 2023 Jan 11;10:1063387. doi: 10.3389/fped.2022.1063387. eCollection 2022.
PubMed 36714640Zhu X, Qi H, Feng Z, Shi Y, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Noninvasive High-Frequency Oscillatory Ventilation vs Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation as Postextubation Support for Preterm Neonates in China: A Randomized Clinical Trial. JAMA Pediatr. 2022 Jun 1;176(6):551-559. doi: 10.1001/jamapediatrics.2022.0710.
PubMed 35467744Seth S, Saha B, Saha AK, Mukherjee S, Hazra A. Nasal HFOV versus nasal IPPV as a post-extubation respiratory support in preterm infants-a randomised controlled trial. Eur J Pediatr. 2021 Oct;180(10):3151-3160. doi: 10.1007/s00431-021-04084-1. Epub 2021 Apr 23.
PubMed 33890156Li Y, Wei Q, Zhao D, Mo Y, Yao L, Li L, Tan W, Pan X, Yao J, Dai W, Zhong D. Non-invasive high-frequency oscillatory ventilation in preterm infants after extubation: a randomized, controlled trial. J Int Med Res. 2021 Feb;49(2):300060520984915. doi: 10.1177/0300060520984915.
PubMed 33641473
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Post Extubation Respiratory Support in Neonates Born At ≥ 26 Weeks' Gestation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07836166
- Acronym / sponsor ID
- NOV-A / 13559
- Conditions
- Extubation Failure in Neonates
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 3 Oct 2028 (estimated)
- Study completion
- 21 Mar 2029 (estimated)
- First posted
- 23 Sep 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.
The goal of this clinical trial is to learn which breathing support works better after removing a newborn's breathing tube. Researchers will study newborns born at 26 weeks of gestation or later. Each newborn will have received breathing support through a tube for at least 24 hours.
The main questions it aims to answer are:
Does noninvasive high-frequency oscillatory ventilation (nHFOV) lower the need to replace the breathing tube within 72 hours? What breathing, feeding, or other medical problems occur with each type of support?
Researchers will compare nHFOV with nasal intermittent mandatory ventilation (NIMV). nHFOV provides very rapid pressure waves through the nose. NIMV provides regular, timed breaths through the nose. The researchers will compare these methods to see which works better after breathing tube removal.
Participants will:
Be assigned by chance to receive either nHFOV or NIMV Receive the assigned breathing support immediately after tube removal Have their breathing, oxygen level, and general condition closely monitored Have blood tests at 1, 12, and 24 hours post extubation to assess their breathing Be monitored for breathing pauses, feeding problems, and other medical problems during hospitalization
Detailed description
Extubation failure, defined as the need to replace an endotracheal breathing tube after planned removal, is associated with longer hospitalization and increased illness and death in newborns. Noninvasive respiratory support may help newborns transition safely from invasive mechanical ventilation. Nasal intermittent mandatory ventilation (NIMV) delivers regular positive pressure breaths through a nasal interface. Noninvasive high frequency oscillatory ventilation (nHFOV) delivers rapid pressure oscillations through a nasal interface and may improve carbon dioxide removal without requiring synchronization with the newborn's breathing. Although both methods are used in neonatal care, evidence directly comparing them in Pakistan is limited.
NOV-A is a prospective, single center, open label, parallel group superiority randomized clinical trial. It will evaluate whether nHFOV lowers extubation failure compared with NIMV after the first planned extubation. Participants will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. An independent biostatistician will generate the allocation sequence. Allocation will remain concealed in sequentially numbered, opaque, sealed envelopes until eligibility and parental consent are confirmed.
Blinding of the treating clinicians is not possible because the two respiratory support methods use different ventilator settings. To limit bias, prespecified clinical and laboratory criteria will guide decisions to replace the breathing tube. The biostatistician will remain unaware of group identities until the primary analysis is complete.
The primary analysis will follow the intention to treat principle. The treatment effect will be reported as the difference between the proportions of participants requiring replacement of the breathing tube, with a two sided 95% confidence interval. A per protocol analysis will be conducted as a sensitivity analysis. An independent Data Safety Monitoring Board will review safety information after approximately 25%, 50%, and 75% of planned enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two arm, parallel group, open-label superiority trial. Participants will be randomly assigned in a 1:1 ratio to receive either noninvasive high frequency oscillatory ventilation or nasal intermittent mandatory ventilation immediately after planned extubation. Randomization will use permuted blocks within three gestational age groups: 26 to 31 weeks and 6 days, 32 to 36 weeks and 6 days, and 37 weeks or later. Each participant will remain in the assigned group for the study intervention.
| Arm | Type | Receives |
|---|---|---|
| Noninvasive High Frequency Oscillatory Ventilation (nHFOV) | Experimental | Device: Noninvasive High Frequency Oscillatory VentilationParticipants assigned to this arm will receive noninvasive high frequency oscillatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O, amplitude will be 15-25 cm H₂O, frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Settings may be adjusted according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. |
| Nasal Intermittent Mandatory Ventilation (NIMV) | Active comparator | Device: Nasal Intermittent Mandatory VentilationParticipants assigned to this arm will receive nasal intermittent mandatory ventilation immediately after their first planned extubation. Respiratory support will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, peak inspiratory pressure will be 18-24 cm H₂O, the initial breathing rate will be 30 breaths per minute, and inspiratory time will be 0.5 seconds. The breathing rate may be increased in steps of 5 to a maximum of 50 breaths per minute according to the participant's clinical condition. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used. |
Who may qualify
- Ages
- 1 day to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age at birth ≥26 weeks (inborn or outborn)
- Postmenstrual age <44 weeks at enrollment according to NICU AKUH admission criteria
- Intubation for respiratory distress or respiratory failure
- Intubated for ≥24 hours
- Undergoing first planned extubation
Key exclusion criteria (7 listed)
- Birth weight <500 g
- Major congenital anomaly affecting cardiac or respiratory function
- Upper airway anomaly
- Neuromuscular disorder affecting respiration
- Requirement for surgical intervention during the study period
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 |
|---|---|---|
| Noninvasive High Frequency Oscillatory VentilationAlso: nHFOV, Nasal High Frequency Oscillatory VentilationnHFOV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Initial mean airway pressure will be 10-12 cm H₂O and may be increased in 1 cm H₂O steps to a maximum of 20 cm H₂O. Initial amplitude will be 15-25 cm H₂O and may be increased in 5 cm H₂O steps to a maximum of 35 cm H₂O. Frequency will be 8-12 Hz, and the inspiratory to expiratory ratio will be 1:1. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Settings will be adjusted according to the participant's clinical condition. | Device | Noninvasive High Frequency Oscillatory Ventilation (nHFOV) |
| Nasal Intermittent Mandatory VentilationAlso: NIMV, Nasal Intermittent Positive Pressure Ventilation, NIPPVNIMV will begin immediately after planned extubation and will be delivered through binasal prongs or a nasal mask. Positive end expiratory pressure will be 8-12 cm H₂O, and peak inspiratory pressure will be 18-24 cm H₂O. The initial breathing rate will be 30 breaths per minute and may be increased in steps of 5 to a maximum of 50 breaths per minute according to carbon dioxide levels and clinical assessment. Inspiratory time will be 0.5 seconds. Oxygen will be adjusted to maintain oxygen saturation between 90% and 95%. Synchronization will not be used. | Device | Nasal Intermittent Mandatory Ventilation (NIMV) |
Primary outcome
Proportion of Participants With Extubation Failure Within 72 Hours
Time frame: Within 72 hours after planned extubation
Extubation failure is defined as reintubation and return to invasive mechanical ventilation within 72 hours after planned extubation. Reintubation will be based on at least one prespecified criterion: pH below 7.20 with carbon dioxide above 65 mmHg, need for 60% or more oxygen to maintain the target oxygen saturation, an episode requiring bag mask ventilation, severe respiratory distress or a Silverman Anderson score of 7 or higher or cardiorespiratory arrest requiring cardiopulmonary resuscitation. The outcome will be reported as the number and percentage of participants with extubation failure in each group.
5 secondary outcomes
Proportion of Participants With Clinically Significant Apnea
Time frame: Within 72 hours after planned extubation
Proportion of Participants With Feeding Intolerance
Time frame: Within 72 hours after planned extubation
Post-extubation blood pH
Time frame: At 1, 12, and 24 hours after planned extubation
Post-extubation partial pressure of carbon dioxide
Time frame: At 1, 12, and 24 hours after planned extubation
Post-extubation SpO₂/FiO₂ ratio
Time frame: At 1, 12, and 24 hours after planned extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 36714640Mei Z, Ming L, Wu Z, Zhu Y. Use of NHFOV vs. NIPPV for the respiratory support of preterm newborns after extubation: A meta-analysis. Front Pediatr. 2023 Jan 11;10:1063387. doi: 10.3389/fped.2022.1063387. eCollection 2022.
- Background: PubMed 35467744Zhu X, Qi H, Feng Z, Shi Y, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Noninvasive High-Frequency Oscillatory Ventilation vs Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation as Postextubation Support for Preterm Neonates in China: A Randomized Clinical Trial. JAMA Pediatr. 2022 Jun 1;176(6):551-559. doi: 10.1001/jamapediatrics.2022.0710.
- Background: PubMed 33890156Seth S, Saha B, Saha AK, Mukherjee S, Hazra A. Nasal HFOV versus nasal IPPV as a post-extubation respiratory support in preterm infants-a randomised controlled trial. Eur J Pediatr. 2021 Oct;180(10):3151-3160. doi: 10.1007/s00431-021-04084-1. Epub 2021 Apr 23.
- Background: PubMed 33641473Li Y, Wei Q, Zhao D, Mo Y, Yao L, Li L, Tan W, Pan X, Yao J, Dai W, Zhong D. Non-invasive high-frequency oscillatory ventilation in preterm infants after extubation: a randomized, controlled trial. J Int Med Res. 2021 Feb;49(2):300060520984915. doi: 10.1177/0300060520984915.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data with external researchers. Participants are newborn infants, and the study will collect sensitive clinical information. The consent and data protection procedures do not provide for unrestricted public release of participant level data. Study findings will be reported in aggregate form through scientific presentations, trial registries, and peer-reviewed publications. Any future request for de-identified participant data would require review and approval by the study investigators, Aga Khan University Ethics Review Committee, and relevant institutional data governance authorities.
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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.
Ali S Hussain, FCPS Paediatrics, Neonatology principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive High Frequency Oscillatory Ventilation and Nasal Intermittent Mandatory Ventilation in people with Extubation Failure in Neonates, run by Aga Khan University at 1 site in Pakistan.
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 7 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: opening soon, as of the sponsor's last update on 23 Sep 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafsah Naz, fellow Paediatric Neonatology (+92 21 33103390, hafsah.naz@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Extubation Failure Within 72 Hours (time frame: Within 72 hours after planned extubation). 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 NCT07836166, which also lists 4 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 23 Sep 2026.