Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation After Extubation in Neonates

NCT07836166 | Not Yet Recruiting DMC

• 1 other identifier: 13559
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Extubation Failure in Neonates

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 72 hours after planned extubation

Secondary Outcomes (5)

• Proportion of Participants With Clinically Significant Apnea

  Within 72 hours after planned extubation

• Proportion of Participants With Feeding Intolerance

  Within 72 hours after planned extubation

• Post-extubation blood pH

  At 1, 12, and 24 hours after planned extubation

• Post-extubation partial pressure of carbon dioxide

  At 1, 12, and 24 hours after planned extubation

• Post-extubation SpO₂/FiO₂ ratio

  At 1, 12, and 24 hours after planned extubation

Other Outcomes (13)

• Time to Extubation Failure

  From planned extubation through 72 hours after extubation

• Proportion of Participants With Air Leak Syndrome

  Up to 7 days after planned extubation or until discontinuation of the assigned nHFOV or NIMV support, whichever occurs first

• Proportion of Participants With Nasal Injury During the Assigned Intervention

  Up to 7 days after planned extubation or until discontinuation of the assigned nHFOV or NIMV support, whichever occurs first

Study Arms (2)

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%.

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.

Device: Nasal Intermittent Mandatory Ventilation

Interventions

Nasal Intermittent Mandatory Ventilation DEVICE

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.

Also known as: NIMV, Nasal Intermittent Positive Pressure Ventilation, NIPPV

Nasal Intermittent Mandatory Ventilation (NIMV)

Noninvasive High Frequency Oscillatory Ventilation DEVICE

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.

Also known as: nHFOV, Nasal High Frequency Oscillatory Ventilation

Noninvasive High Frequency Oscillatory Ventilation (nHFOV)

Eligibility Criteria

• Age: 1 Day - 18 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 36714640 BACKGROUND

• Zhu 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.

  PMID: 35467744 BACKGROUND

• Seth 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.

  PMID: 33890156 BACKGROUND

• Li 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.

  PMID: 33641473 BACKGROUND

Study Officials

• Ali S Hussain, FCPS Paediatrics, Neonatology

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafsah Naz, fellow Paediatric Neonatology

CONTACT

+92 21 33103390; hafsah.naz@aku.edu

Ali S Hussain, MBBS, FCPS Paediatrics,NICU

CONTACT

+92 300 2424206; ali.hussain@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The independent biostatistician conducting the primary analysis will be masked to the intervention identities. The study groups will be coded as Group A and Group B until the primary analysis is completed. This explains why the trial is registered as open-label while the statistical analysis remains masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Paediatrics

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 3, 2028
• Study Completion (Estimated): March 21, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)