Respiratory Distress Syndrome (RDS)NOV-RDSNCT07837141
Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates
A study testing Noninvasive High Frequency Oscillatory Ventilation and Nasal Intermittent Mandatory Ventilation in people with Respiratory Distress Syndrome (RDS) and Newborn, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Respiratory Distress Syndrome (RDS), Newborn, Premature Birth
- 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
- 158 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to Dec 2027
- 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 0 to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates born between 28+0 and 36+0 weeks of gestation, whether inborn or outborn
- Gestational age confirmed by first-trimester ultrasound, last menstrual period, or Ballard score
- Clinical and radiological evidence of respiratory distress syndrome
- Requirement for NIMV-level noninvasive respiratory support according to the protocol-defined criteria
- Enrollment and randomization within 6 hours after birth
- Written informed consent provided by a parent or legal guardian
Who cannot join
- Intubation and receipt of invasive mechanical ventilation at the time of enrollment
- Receipt of surfactant before randomization by any method, including INSURE, LISA, MIST, or surfactant administration before transfer to Aga Khan University Hospital
- Major congenital anomaly affecting respiratory or cardiovascular physiology
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, +92 331 0478376 ext. 3390, hafsah.naz@aku.edu
Shahzaib Salim, 02134869731 ext. 69731, hafsah.naz@aku.edu
About this study
Official title: Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Primary Respiratory Support in Preterm Neonates With Respiratory Distress Syndrome: A Non Inferiority Randomized Controlled Trial
The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe.
The main questions it aims to answer are:
Read more
Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support?
Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital.
Babies will:
Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required
The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.
Read the detailed description
Direct comparisons of nasal high frequency oscillatory ventilation (nHFOV) and nasal intermittent mandatory ventilation (NIMV) as primary respiratory support for preterm neonates with respiratory distress syndrome are limited, particularly in Pakistan and other lower middle income settings. Both methods are routinely used at Aga Khan University Hospital, but the choice between them currently depends mainly on the treating clinician's preference. This study is intended to provide local evidence that may guide a more standardized approach to early noninvasive respiratory support.
This is a prospective, single center, open label, parallel group, non inferiority randomized controlled trial. A total of 158 neonates will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent biostatistician. Because the two ventilation modes use visibly different settings, treating clinicians and research personnel will not be blinded. Statistical analysis will remain blinded until completion of the primary analysis.
The primary analysis will estimate the risk difference in treatment failure between the nHFOV and NIMV groups with a two-sided 95% confidence interval. nHFOV will be considered non-inferior if the upper limit of the confidence interval is below the prespecified absolute non-inferiority margin of 15 percentage points. Both intention to treat and per protocol analyses will be performed. An independent Data and Safety Monitoring Board will review safety data after approximately 25%, 50%, and 75% of planned enrollment.
- Being tested
- Noninvasive High Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation
- Keywords
- Preterm Neonates, Neonatal Respiratory Distress Syndrome, Noninvasive High-Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation, Primary Respiratory Support, Noninvasive Respiratory Support, Treatment Failure, Invasive Mechanical Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, 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.
Noninvasive High Frequency Oscillatory VentilationDevice
Also called nHFOV, Nasal High Frequency Oscillatory Ventilation
Noninvasive high frequency oscillatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an nHFOV capable ventilator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Mean airway pressure may be increased by 1 cmH₂O to a maximum of 20 cmH₂O, and amplitude may be increased by 5 cmH₂O to a maximum of 35 cmH₂O. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
Nasal Intermittent Mandatory VentilationDevice
Also called NIMV, Nasal Intermittent Positive Pressure Ventilation, NIPPV
Nasal intermittent mandatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an NIMV capable ventilator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. The respiratory rate may be increased by 5 breaths per minute to a maximum of 50 breaths per minute based on PaCO₂. FiO₂ and other ventilator settings may be adjusted according to clinical response to maintain SpO₂ between 90% and 95%.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High-Frequency Oscillatory Ventilation (nHFOV) | Experimental | Preterm neonates randomized to this arm will receive nasal high frequency oscillatory ventilation (nHFOV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. Receives: Device: Noninvasive High Frequency Oscillatory Ventilation |
| Nasal Intermittent Mandatory Ventilation (NIMV) | Active comparator | Preterm neonates randomized to this arm will receive nasal intermittent mandatory ventilation (NIMV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. Settings, including FiO₂, will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. 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 preterm neonates with treatment failure requiring invasive mechanical ventilation
Treatment failure is defined as initiation of invasive mechanical ventilation due to any of the following: pH <7.20 with pCO₂ >60 mmHg on two blood gas measurements at least 30 minutes apart, SpO₂ <90% with FiO₂ >0.60 for at least 15 minutes on maximal noninvasive support; at least one apnea episode requiring bag mask ventilation; Silverman Anderson Score ≥7 on maximal noninvasive support; hemodynamic instability requiring inotropic support secondary to respiratory failure, or the physician's decision to intubate for clinical reasons with written justification. The number and proportion of neonates meeting the treatment failure criteria will be reported in each study arm.
Measured: Within 72 hours after randomization
Secondary outcomes (3)
Proportion of Eligible Neonates With Bronchopulmonary Dysplasia at 36 Weeks' Postmenstrual Age Description
Among enrolled neonates born at ≤32 weeks' gestation who survive to 36 weeks' PMA, BPD will be classified according to respiratory support at 36 weeks using Jensen et al. (2019): no BPD, no respiratory support; Grade 1, nasal cannula ≤2 L/min; Grade 2, nasal cannula >2 L/min or noninvasive positive-pressure support; and Grade 3, invasive mechanical ventilation. Respiratory status will be obtained from inpatient records, outpatient assessment, or telephone follow-up. Neonates who die before 36 weeks' PMA will be excluded from BPD ascertainment.
Measured: At 36 weeks' postmenstrual age
Proportion of eligible neonates with severe intraventricular hemorrhage
The proportion of enrolled neonates born at <32 weeks' gestation or with a birth weight <1,500 g who develop severe IVH will be reported for each study arm. Severe IVH is defined according to the Papile classification as Grade III, IVH occupying ≥50% of the ventricular area with ventricular dilatation, or Grade IV, IVH with periventricular echodensity consistent with periventricular hemorrhagic infarction. All routine and clinically indicated cranial ultrasounds obtained during the assessment period will be included and reported by a consultant radiologist blinded to treatment allocation.
Measured: From randomization until 44 weeks' postmenstrual age or final hospital disposition, whichever occurs first
Proportion of Eligible Neonates With Treatment-Requiring Retinopathy of Prematurity
The proportion of enrolled neonates born at <32 weeks' gestation or with a birth weight <1,500 g who develop treatment-requiring ROP in either eye will be reported for each study arm. Screening will be performed by a consultant ophthalmologist, and ROP will be classified according to ICROP3. Treatment-requiring ROP is defined as Type 1 ROP-Zone I ROP of any stage with plus disease, Zone I Stage 3 without plus disease, or Zone II Stage 2 or 3 with plus disease-aggressive ROP, or Stage 4 or 5 ROP. Treatment may include laser photocoagulation, intravitreal anti-VEGF therapy, or vitreoretinal surgery. Findings will be obtained from inpatient records and scheduled post-discharge ophthalmology follow-up.
Measured: From the first ROP screening examination until 44 weeks' postmenstrual age or discharge from ROP screening by the treating ophthalmologist, whichever occurs first
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 completionOct 2027 (estimated)
- Study completionDec 2027 (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 Respiratory Distress Syndrome (RDS)Studies 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
- Participants will be assigned in a 1:1 ratio to two parallel groups receiving either nHFOV or NIMV. Stratified permuted-block randomization will be used according to gestational age: 28+0 to 31+6 weeks and 32+0 to 36+0 weeks.
- Masking
- None (open label)
- Enrolment
- 158 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 (Paeds),FCPS Neonatology, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837141
- Sponsor's protocol ID
- 13551
- Acronym
- NOV-RDS
- 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: Individual participant data will not be shared because the study involves a vulnerable neonatal population, and no external IPD sharing repository or formal data sharing framework has been established. Study findings will be reported in aggregate form through trial registration, scientific presentations, and peer-reviewed publication, without disclosing participant identities.
Publications
Ali R, Mahmud S. Nasal high-frequency oscillatory ventilation versus nasal intermittent positive pressure ventilation in pre-terms with respiratory distress syndrome during the early neonatal period: a randomized controlled trial. Pakistan Armed Forces Medical Journal. 2023;73(1):151-154. doi:10.51253/pafmj.v73i1.8186.
Likhitha P, Ramaswamy VV, Shaik NB, Basany L, Ali AAH. Non-invasive high-frequency oscillation ventilation versus nasal CPAP as primary respiratory support in preterm neonates >/= 30 weeks with RDS: a non-inferiority randomized controlled trial. Eur J Pediatr. 2026 Mar 25;185(4):210. doi: 10.1007/s00431-026-06887-6.
PubMed 41876901Zhu X, Feng Z, Liu C, Shi L, Shi Y, Ramanathan R; NHFOV study group. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial. Neonatology. 2021;118(3):325-331. doi: 10.1159/000515226. Epub 2021 Apr 7.
PubMed 33827081Rachana RD, Oleti T, Saikiran D, Vardhelli V, Thiruveedi S, Hussain A, Tamatam PR. Non-invasive high-frequency oscillatory ventilation versus non-invasive intermittent mandatory ventilation as a rescue mode in preterm infants with respiratory distress on nasal CPAP-a randomized control trial. Eur J Pediatr. 2025 Feb 22;184(3):205. doi: 10.1007/s00431-025-06041-8.
PubMed 39985666
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
- Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Primary Respiratory Support in Preterm Neonates With Respiratory Distress Syndrome: A Non Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07837141
- Acronym / sponsor ID
- NOV-RDS / 13551
- Keywords
- Preterm Neonates, Neonatal Respiratory Distress Syndrome, Noninvasive High-Frequency Oscillatory Ventilation, Nasal Intermittent Mandatory Ventilation, Primary Respiratory Support, Noninvasive Respiratory Support, Treatment Failure, Invasive Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (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 if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe.
The main questions it aims to answer are:
Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support?
Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital.
Babies will:
Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required
The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.
Detailed description
Direct comparisons of nasal high frequency oscillatory ventilation (nHFOV) and nasal intermittent mandatory ventilation (NIMV) as primary respiratory support for preterm neonates with respiratory distress syndrome are limited, particularly in Pakistan and other lower middle income settings. Both methods are routinely used at Aga Khan University Hospital, but the choice between them currently depends mainly on the treating clinician's preference. This study is intended to provide local evidence that may guide a more standardized approach to early noninvasive respiratory support.
This is a prospective, single center, open label, parallel group, non inferiority randomized controlled trial. A total of 158 neonates will be assigned in a 1:1 ratio using stratified permuted block randomization based on gestational age. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent biostatistician. Because the two ventilation modes use visibly different settings, treating clinicians and research personnel will not be blinded. Statistical analysis will remain blinded until completion of the primary analysis.
The primary analysis will estimate the risk difference in treatment failure between the nHFOV and NIMV groups with a two-sided 95% confidence interval. nHFOV will be considered non-inferior if the upper limit of the confidence interval is below the prespecified absolute non-inferiority margin of 15 percentage points. Both intention to treat and per protocol analyses will be performed. An independent Data and Safety Monitoring Board will review safety data 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
- Participants will be assigned in a 1:1 ratio to two parallel groups receiving either nHFOV or NIMV. Stratified permuted-block randomization will be used according to gestational age: 28+0 to 31+6 weeks and 32+0 to 36+0 weeks.
| Arm | Type | Receives |
|---|---|---|
| Nasal High-Frequency Oscillatory Ventilation (nHFOV) | Experimental | Device: Noninvasive High Frequency Oscillatory VentilationPreterm neonates randomized to this arm will receive nasal high frequency oscillatory ventilation (nHFOV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. |
| Nasal Intermittent Mandatory Ventilation (NIMV) | Active comparator | Device: Nasal Intermittent Mandatory VentilationPreterm neonates randomized to this arm will receive nasal intermittent mandatory ventilation (NIMV) as primary respiratory support through a RAM cannula or Infant Flow Generator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. Settings, including FiO₂, will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm neonates born between 28+0 and 36+0 weeks of gestation, whether inborn or outborn
- Gestational age confirmed by first-trimester ultrasound, last menstrual period, or Ballard score
- Clinical and radiological evidence of respiratory distress syndrome
- Requirement for NIMV-level noninvasive respiratory support according to the protocol-defined criteria
- Enrollment and randomization within 6 hours after birth
Key exclusion criteria (3 listed)
- Intubation and receipt of invasive mechanical ventilation at the time of enrollment
- Receipt of surfactant before randomization by any method, including INSURE, LISA, MIST, or surfactant administration before transfer to Aga Khan University Hospital
- Major congenital anomaly affecting respiratory or cardiovascular physiology
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 VentilationNoninvasive high frequency oscillatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an nHFOV capable ventilator. Initial settings will include mean airway pressure of 10-12 cmH₂O, amplitude of 15-25 cmH₂O, frequency of 8-12 Hz, and an inspiratory to expiratory ratio of 1:1. Mean airway pressure may be increased by 1 cmH₂O to a maximum of 20 cmH₂O, and amplitude may be increased by 5 cmH₂O to a maximum of 35 cmH₂O. Settings will be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. | Device | Nasal High-Frequency Oscillatory Ventilation (nHFOV) |
| Nasal Intermittent Mandatory VentilationAlso: NIMV, Nasal Intermittent Positive Pressure Ventilation, NIPPVNasal intermittent mandatory ventilation will be delivered as primary respiratory support through a nasal interface using a RAM cannula or Infant Flow Generator and an NIMV capable ventilator. Initial settings will include PEEP of 8-12 cmH₂O, peak inspiratory pressure of 18-24 cmH₂O, inspiratory time of 0.5 seconds, and respiratory rate of 30 breaths per minute. The respiratory rate may be increased by 5 breaths per minute to a maximum of 50 breaths per minute based on PaCO₂. FiO₂ and other ventilator settings may be adjusted according to clinical response to maintain SpO₂ between 90% and 95%. | Device | Nasal Intermittent Mandatory Ventilation (NIMV) |
Primary outcome
Proportion of preterm neonates with treatment failure requiring invasive mechanical ventilation
Time frame: Within 72 hours after randomization
Treatment failure is defined as initiation of invasive mechanical ventilation due to any of the following: pH <7.20 with pCO₂ >60 mmHg on two blood gas measurements at least 30 minutes apart, SpO₂ <90% with FiO₂ >0.60 for at least 15 minutes on maximal noninvasive support; at least one apnea episode requiring bag mask ventilation; Silverman Anderson Score ≥7 on maximal noninvasive support; hemodynamic instability requiring inotropic support secondary to respiratory failure, or the physician's decision to intubate for clinical reasons with written justification. The number and proportion of neonates meeting the treatment failure criteria will be reported in each study arm.
3 secondary outcomes
Proportion of Eligible Neonates With Bronchopulmonary Dysplasia at 36 Weeks' Postmenstrual Age Description
Time frame: At 36 weeks' postmenstrual age
Proportion of eligible neonates with severe intraventricular hemorrhage
Time frame: From randomization until 44 weeks' postmenstrual age or final hospital disposition, whichever occurs first
Proportion of Eligible Neonates With Treatment-Requiring Retinopathy of Prematurity
Time frame: From the first ROP screening examination until 44 weeks' postmenstrual age or discharge from ROP screening by the treating ophthalmologist, whichever occurs first
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.
- BackgroundAli R, Mahmud S. Nasal high-frequency oscillatory ventilation versus nasal intermittent positive pressure ventilation in pre-terms with respiratory distress syndrome during the early neonatal period: a randomized controlled trial. Pakistan Armed Forces Medical Journal. 2023;73(1):151-154. doi:10.51253/pafmj.v73i1.8186.
- Background: PubMed 41876901Likhitha P, Ramaswamy VV, Shaik NB, Basany L, Ali AAH. Non-invasive high-frequency oscillation ventilation versus nasal CPAP as primary respiratory support in preterm neonates >/= 30 weeks with RDS: a non-inferiority randomized controlled trial. Eur J Pediatr. 2026 Mar 25;185(4):210. doi: 10.1007/s00431-026-06887-6.
- Background: PubMed 33827081Zhu X, Feng Z, Liu C, Shi L, Shi Y, Ramanathan R; NHFOV study group. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial. Neonatology. 2021;118(3):325-331. doi: 10.1159/000515226. Epub 2021 Apr 7.
- Background: PubMed 39985666Rachana RD, Oleti T, Saikiran D, Vardhelli V, Thiruveedi S, Hussain A, Tamatam PR. Non-invasive high-frequency oscillatory ventilation versus non-invasive intermittent mandatory ventilation as a rescue mode in preterm infants with respiratory distress on nasal CPAP-a randomized control trial. Eur J Pediatr. 2025 Feb 22;184(3):205. doi: 10.1007/s00431-025-06041-8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a vulnerable neonatal population, and no external IPD sharing repository or formal data sharing framework has been established. Study findings will be reported in aggregate form through trial registration, scientific presentations, and peer-reviewed publication, without disclosing participant identities.
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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 (Paeds),FCPS 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 Respiratory Distress Syndrome (RDS) and Newborn, 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 6 inclusion and 3 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 3310478376 ext. 3390, 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 preterm neonates with treatment failure requiring invasive mechanical ventilation (time frame: Within 72 hours after randomization). 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 NCT07837141, 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.