Respiratory Distress Syndrome in Premature InfantnHFOVNCT04914715
nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
A study testing Non-invasive High Frequency Oscillatory Ventilation and Conventional Invasive Ventilation in people with Respiratory Distress Syndrome in Premature Infant, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial summary
Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Non-invasive High Frequency Oscillatory Ventilation and Conventional Invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2021to 30 Dec 2023
- 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 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS
- Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation > 90% on fio2 of 40% in 1st 6 hours of life.
- Capillary PCO2 of > 70 or arterial PCO2 > 65 on two repeated sampling within 4 hours
- Neonates whose parents consented to participate.
Who cannot join
- All preterm babies who are below < 26 weeks above the 34 weeks of gestation
- Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support.
- Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis.
- Patient with poor respiratory drive due to any reason neurological or central causes
- Diaphragmatic hernia or any other thoracic anomaly
- Pleural effusion unilateral or bilateral
Show all 10Show fewer
- Congenital cystic pulmonary malformation.
- Neonates with underlying cyanotic heart disease.
- Neonates with acynotic heart disease causing pulmonary edema
- Neonates with cleft lip and cleft palate or any other surgical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Non-invasive High Frequency Oscillatory Ventilation (nHFOV) Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non-invasive is relatively safe but non-invasive high frequency oscillatory ventilation (nHFOV) is not appropriately evaluated in neonates as primary support. So the investigators hypothesized that nHFOV is relatively safe and effective in comparison with invasive ventilation for preterm neonates with RDS.
Read the detailed description
Respiratory distress is a common morbidity in preterm neonates that requires respiratory support and surfactant replacement, if not adequately and timely managed may cause multi-organ dysfunction. Respiratory support can be delivered via both non-invasive (NIV) and invasive mode depending upon the availability of ventilators ,experience and comfort level of physician, and availability of department protocol.
Non-invasive ventilation include CPAP (Continuous Positive Airway Pressure), NIPPV (Non-invasive Positive Pressure Ventilation) and nHFOV (Non-invasive High Frequency Oscillatory Ventilation). Non-invasive ventilation is currently the preferred mode of ventilation globally due to its safety profile, early weaning, less barotrauma, volume trauma and other complications.
Literature review reveals reported comparison for some non-invasive modes of ventilation like CPAP and NIPPV versus conventional ventilation however other non-invasive modes such as nHFOV have still not been appropriately evaluated. nHFOV provides 60-1200 breath/minute with minimal tidal volume while keeping the lungs expanded with equal distribution of air in whole lung so less chances of barotrauma and volutrauma. Extra pressure which is not needed by the lung is dissipated through oral cavity and esophagus to the stomach. Few observational studies reported that extubation failure is better prevented with utilization of NHFOV.
For preterm neonates with RDS nHFOV compared with nCPAP showed better results in term of short duration of intervention, less chances of failure, low incidence of intraventricular hemorrhage, and other respiratory complications were almost equal.
A multicenter double, blinded, randomized controlled trial is under process for using non-invasive ventilation to prevent extubation failure. Another randomized controlled cross over trial performed in a small number of extreme preterm does showed better clearance of carbon dioxide with nHFOV compared with CPAP.
Retrospective cohort study published recently evaluating the use of non-invasive ventilation (nCPAP, SNIPPV and nHFOV) for preterm neonates with RDS, showed satisfactory outcomes with nHFOV with fewer babies requiring invasive ventilation.
A metanalysis of Randomized Controlled Trials of studies evaluating the use of nHFOV, nCPAP and biphasic CPAP; published recently showed nHFOV to be more effective as compared to other modes. The primary outcome of the RCT included in the meta analysis was decreased chances of intubation and better clearance of carbon dioxide.
In this study investigators will include inborn preterm neonates with no antenatal, perinatal risk factor or anomalies that can affect the outcome. Those babies who developed respiratory distress syndrome at birth and does not need early invasive ventilation will be recruited in study. Study will be conducted in almost 10 centers in Pakistan and Russia, total 1200 babies will be included from all centers. After all teaching and training regarding management strategies and equipment utilization. Recruited participants will be further divided in two arms, one in intervention arm (nHFOV) and other is control arm (Invasive Conventional) ventilation. Outcome will be assessed for respiratory support, surfactant requirement, duration of respiratory support, response to therapy and complications related to respiratory support.
- Being tested
- Non-invasive High Frequency Oscillatory Ventilation, Conventional Invasive Ventilation
- Keywords
- nHFOV, RDS, CPAP, Respiratory failure, Respiratory support
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive High Frequency Oscillatory VentilationDevice
Also called Conventional Invasive Ventilation
We are planning to use (Medin-CNO) for non-invasive ventilation. This machine has option to deliver NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option.
Conventional Invasive VentilationDevice
Invasive ventilation will be started following endotracheal intubation, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive High Frequency Oscillatory Ventilation | Experimental | Preterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirefment more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings.
Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option. Receives: Device: Non-invasive High Frequency Oscillatory Ventilation |
| Conventional Invasive Ventilation | Active comparator | Preterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirement more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings.
Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to invasive ventilation through endotracheal tube, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40. Receives: Device: Conventional Invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Support Escalation
After starting with intervention or control group, baby will be monitored for further escalation of respiratory support like baby is Conventional Invasive Ventilation needs High frequency oscillatory ventilation. Baby started on NHFOV need invasive ventilation.
Measured: within first 24 hours of intervention
Oxygen Requirement
With assigned intervention or comparator, baby will be monitored for oxygen requirement comparing with baseline oxygen demand or > 40% of fractional Inspiratory oxygen.
Measured: Within first 24 hours
Weaning from Assigned respiratory support
Babies started on intervention or comparator will be monitored for weaning from respiratory support in hours after starting respiratory support.
Measured: within 1-2 weeks of respiratory support starting
Secondary outcomes (4)
Number of Surfactant Needed
Both groups will be compared for number of surfactant needed
Measured: within first 3 days of assignment
Respiratory Support Duration
Both groups will be compared for respiratory support duration in hours
Measured: up to 2 weeks
Complications related to respiratory support
Both groups will be compared for complication like pneumothorax, atelectasis, Collapse, pneumonia and bronchopulmonary dysplasia.
Measured: Within 1 week after respiratory support discontinuation
Complication related to prematurity
both groups will be compared for complication of prematurity like intraventricular hemorage, Patent Ductus Arteriosus, Intraventricular Hemorrhage, necrotizing enterocollitis, and nosocomial infection
Measured: Within 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start30 Jun 2021
- Primary completion30 Jun 2023
- Study completion30 Dec 2023
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 Respiratory Distress Syndrome in Premature InfantStudies 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
- Randomization will be done via random allocation software 1.0.0. This software produces as its output a sequence of allocation based on selected type. Considering 2 groups with equal sample size, a simple random allocation list will be generated using block randomization. The list will be used to create Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) to assure allocation concealment. The process of randomization will be conducted by Indus Hospital Research Centre (IHRC) independently.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed RA Rehan Ali, FRCPCH, Principal investigator, The Indus Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914715
- Sponsor's protocol ID
- 2021_01_09
- Acronym
- nHFOV
- Status last verified
- Jun 2021
- First submitted
- 17 Mar 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to maintain data confidentiality, it will not be shared with other researcher
Publications
Sankar MJ, Gupta N, Jain K, Agarwal R, Paul VK. Efficacy and safety of surfactant replacement therapy for preterm neonates with respiratory distress syndrome in low- and middle-income countries: a systematic review. J Perinatol. 2016 May;36 Suppl 1(Suppl 1):S36-48. doi: 10.1038/jp.2016.31.
PubMed 27109091Wheeler CR, Smallwood CD. 2019 Year in Review: Neonatal Respiratory Support. Respir Care. 2020 May;65(5):693-704. doi: 10.4187/respcare.07720. Epub 2020 Mar 24.
PubMed 32209710Boel L, Broad K, Chakraborty M. Non-invasive respiratory support in newborn infants. Paediatrics and Child Health. 2018;28(1):6-12.
Fischer H. Efficacy and safety of non-invasive respiratory support in neonates. 2018.
Batey N, Bustani P. Neonatal high-frequency oscillatory ventilation. Paediatrics and Child Health. 2020;30(4):149-53.
Fischer HS, Bohlin K, Buhrer C, Schmalisch G, Cremer M, Reiss I, Czernik C. Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep 18.
PubMed 25227281Huang J, Yuan L, Chen C. [Research advances in noninvasive high-frequency oscillatory ventilation in neonates]. Zhongguo Dang Dai Er Ke Za Zhi. 2017 May;19(5):607-611. doi: 10.7499/j.issn.1008-8830.2017.05.025. Chinese.
PubMed 28506358Iranpour R, Armanian AM, Abedi AR, Farajzadegan Z. Nasal high-frequency oscillatory ventilation (nHFOV) versus nasal continuous positive airway pressure (NCPAP) as an initial therapy for respiratory distress syndrome (RDS) in preterm and near-term infants. BMJ Paediatr Open. 2019 Jul 14;3(1):e000443. doi: 10.1136/bmjpo-2019-000443. eCollection 2019.
PubMed 31414062Shi Y, De Luca D; NASal OscillatioN post-Extubation (NASONE) study group. Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.
PubMed 31349833Bottino R, Pontiggia F, Ricci C, Gambacorta A, Paladini A, Chijenas V, Liubsys A, Navikiene J, Pliauckiene A, Mercadante D, Colnaghi M, Tana M, Tirone C, Lio A, Aurilia C, Pastorino R, Purcaro V, Maffei G, Liberatore P, Consigli C, Haass C, Lista G, Agosti M, Mosca F, Vento G. Nasal high-frequency oscillatory ventilation and CO2 removal: A randomized controlled crossover trial. Pediatr Pulmonol. 2018 Sep;53(9):1245-1251. doi: 10.1002/ppul.24120. Epub 2018 Jul 12.
PubMed 29999596
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-invasive High Frequency Oscillatory Ventilation (nHFOV) Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04914715
- Acronym / sponsor ID
- nHFOV / 2021_01_09
- Keywords
- nHFOV, RDS, CPAP, Respiratory failure, Respiratory support
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 7 Jun 2021 (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.
Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non-invasive is relatively safe but non-invasive high frequency oscillatory ventilation (nHFOV) is not appropriately evaluated in neonates as primary support. So the investigators hypothesized that nHFOV is relatively safe and effective in comparison with invasive ventilation for preterm neonates with RDS.
Detailed description
Respiratory distress is a common morbidity in preterm neonates that requires respiratory support and surfactant replacement, if not adequately and timely managed may cause multi-organ dysfunction. Respiratory support can be delivered via both non-invasive (NIV) and invasive mode depending upon the availability of ventilators ,experience and comfort level of physician, and availability of department protocol.
Non-invasive ventilation include CPAP (Continuous Positive Airway Pressure), NIPPV (Non-invasive Positive Pressure Ventilation) and nHFOV (Non-invasive High Frequency Oscillatory Ventilation). Non-invasive ventilation is currently the preferred mode of ventilation globally due to its safety profile, early weaning, less barotrauma, volume trauma and other complications.
Literature review reveals reported comparison for some non-invasive modes of ventilation like CPAP and NIPPV versus conventional ventilation however other non-invasive modes such as nHFOV have still not been appropriately evaluated. nHFOV provides 60-1200 breath/minute with minimal tidal volume while keeping the lungs expanded with equal distribution of air in whole lung so less chances of barotrauma and volutrauma. Extra pressure which is not needed by the lung is dissipated through oral cavity and esophagus to the stomach. Few observational studies reported that extubation failure is better prevented with utilization of NHFOV.
For preterm neonates with RDS nHFOV compared with nCPAP showed better results in term of short duration of intervention, less chances of failure, low incidence of intraventricular hemorrhage, and other respiratory complications were almost equal.
A multicenter double, blinded, randomized controlled trial is under process for using non-invasive ventilation to prevent extubation failure. Another randomized controlled cross over trial performed in a small number of extreme preterm does showed better clearance of carbon dioxide with nHFOV compared with CPAP.
Retrospective cohort study published recently evaluating the use of non-invasive ventilation (nCPAP, SNIPPV and nHFOV) for preterm neonates with RDS, showed satisfactory outcomes with nHFOV with fewer babies requiring invasive ventilation.
A metanalysis of Randomized Controlled Trials of studies evaluating the use of nHFOV, nCPAP and biphasic CPAP; published recently showed nHFOV to be more effective as compared to other modes. The primary outcome of the RCT included in the meta analysis was decreased chances of intubation and better clearance of carbon dioxide.
In this study investigators will include inborn preterm neonates with no antenatal, perinatal risk factor or anomalies that can affect the outcome. Those babies who developed respiratory distress syndrome at birth and does not need early invasive ventilation will be recruited in study. Study will be conducted in almost 10 centers in Pakistan and Russia, total 1200 babies will be included from all centers. After all teaching and training regarding management strategies and equipment utilization. Recruited participants will be further divided in two arms, one in intervention arm (nHFOV) and other is control arm (Invasive Conventional) ventilation. Outcome will be assessed for respiratory support, surfactant requirement, duration of respiratory support, response to therapy and complications related to respiratory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be done via random allocation software 1.0.0. This software produces as its output a sequence of allocation based on selected type. Considering 2 groups with equal sample size, a simple random allocation list will be generated using block randomization. The list will be used to create Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) to assure allocation concealment. The process of randomization will be conducted by Indus Hospital Research Centre (IHRC) independently.
| Arm | Type | Receives |
|---|---|---|
| Non-invasive High Frequency Oscillatory Ventilation | Experimental | Device: Non-invasive High Frequency Oscillatory VentilationPreterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirefment more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings. Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option. |
| Conventional Invasive Ventilation | Active comparator | Device: Conventional Invasive VentilationPreterm babies (26-28 weeks) born with respiratory distress will be initially started on nCPAP with setting of flow 6-8 liter, PEEP 5-6, FiO2 21-40%. If fio2 requirement more than 40%, surfactant will be given in first 2 hours of birth. If baby fails on CPAP then will be switched to nHFOV with below mentioned settings. Preterm born babies 28-34 weeks gestation with RDS, respiratory support will be started on Heated Humidified High Flow Oxygen therapy or nCPAP, if that fails then baby will be switched to invasive ventilation through endotracheal tube, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40. |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS
- Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation > 90% on fio2 of 40% in 1st 6 hours of life.
- Capillary PCO2 of > 70 or arterial PCO2 > 65 on two repeated sampling within 4 hours
- Neonates whose parents consented to participate.
Key exclusion criteria (10 listed)
- All preterm babies who are below < 26 weeks above the 34 weeks of gestation
- Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support.
- Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis.
- Patient with poor respiratory drive due to any reason neurological or central causes
- Diaphragmatic hernia or any other thoracic anomaly
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 |
|---|---|---|
| Non-invasive High Frequency Oscillatory VentilationAlso: Conventional Invasive VentilationWe are planning to use (Medin-CNO) for non-invasive ventilation. This machine has option to deliver NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option. | Device | Non-invasive High Frequency Oscillatory Ventilation |
| Conventional Invasive VentilationInvasive ventilation will be started following endotracheal intubation, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40. | Device | Conventional Invasive Ventilation |
Primary outcome
Respiratory Support Escalation
Time frame: within first 24 hours of intervention
After starting with intervention or control group, baby will be monitored for further escalation of respiratory support like baby is Conventional Invasive Ventilation needs High frequency oscillatory ventilation. Baby started on NHFOV need invasive ventilation.
Oxygen Requirement
Time frame: Within first 24 hours
With assigned intervention or comparator, baby will be monitored for oxygen requirement comparing with baseline oxygen demand or > 40% of fractional Inspiratory oxygen.
Weaning from Assigned respiratory support
Time frame: within 1-2 weeks of respiratory support starting
Babies started on intervention or comparator will be monitored for weaning from respiratory support in hours after starting respiratory support.
4 secondary outcomes
Number of Surfactant Needed
Time frame: within first 3 days of assignment
Respiratory Support Duration
Time frame: up to 2 weeks
Complications related to respiratory support
Time frame: Within 1 week after respiratory support discontinuation
Complication related to prematurity
Time frame: Within 1week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 27109091Sankar MJ, Gupta N, Jain K, Agarwal R, Paul VK. Efficacy and safety of surfactant replacement therapy for preterm neonates with respiratory distress syndrome in low- and middle-income countries: a systematic review. J Perinatol. 2016 May;36 Suppl 1(Suppl 1):S36-48. doi: 10.1038/jp.2016.31.
- Background: PubMed 32209710Wheeler CR, Smallwood CD. 2019 Year in Review: Neonatal Respiratory Support. Respir Care. 2020 May;65(5):693-704. doi: 10.4187/respcare.07720. Epub 2020 Mar 24.
- BackgroundBoel L, Broad K, Chakraborty M. Non-invasive respiratory support in newborn infants. Paediatrics and Child Health. 2018;28(1):6-12.
- BackgroundFischer H. Efficacy and safety of non-invasive respiratory support in neonates. 2018.
- BackgroundBatey N, Bustani P. Neonatal high-frequency oscillatory ventilation. Paediatrics and Child Health. 2020;30(4):149-53.
- Background: PubMed 25227281Fischer HS, Bohlin K, Buhrer C, Schmalisch G, Cremer M, Reiss I, Czernik C. Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep 18.
- Background: PubMed 28506358Huang J, Yuan L, Chen C. [Research advances in noninvasive high-frequency oscillatory ventilation in neonates]. Zhongguo Dang Dai Er Ke Za Zhi. 2017 May;19(5):607-611. doi: 10.7499/j.issn.1008-8830.2017.05.025. Chinese.
- Background: PubMed 31414062Iranpour R, Armanian AM, Abedi AR, Farajzadegan Z. Nasal high-frequency oscillatory ventilation (nHFOV) versus nasal continuous positive airway pressure (NCPAP) as an initial therapy for respiratory distress syndrome (RDS) in preterm and near-term infants. BMJ Paediatr Open. 2019 Jul 14;3(1):e000443. doi: 10.1136/bmjpo-2019-000443. eCollection 2019.
- Background: PubMed 31349833Shi Y, De Luca D; NASal OscillatioN post-Extubation (NASONE) study group. Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.
- Background: PubMed 29999596Bottino R, Pontiggia F, Ricci C, Gambacorta A, Paladini A, Chijenas V, Liubsys A, Navikiene J, Pliauckiene A, Mercadante D, Colnaghi M, Tana M, Tirone C, Lio A, Aurilia C, Pastorino R, Purcaro V, Maffei G, Liberatore P, Consigli C, Haass C, Lista G, Agosti M, Mosca F, Vento G. Nasal high-frequency oscillatory ventilation and CO2 removal: A randomized controlled crossover trial. Pediatr Pulmonol. 2018 Sep;53(9):1245-1251. doi: 10.1002/ppul.24120. Epub 2018 Jul 12.
- Individual participant dataSharing planned: No. In order to maintain data confidentiality, it will not be shared with other researcher
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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.
Syed RA Rehan Ali, FRCPCH principal investigator
The Indus Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive High Frequency Oscillatory Ventilation and Conventional Invasive Ventilation in people with Respiratory Distress Syndrome in Premature Infant, run by Indus Hospital and Health Network 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 12 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Respiratory Support Escalation (time frame: within first 24 hours of intervention). The study lists 3 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 NCT04914715, 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 12 Mar 2024.