Transient Tachypnea of the NewbornNCT03006354
nHFOV Versus nCPAP in Transient Tachypnea of the Newborn
A study testing nHFOV and nCPAP in people with Transient Tachypnea of the Newborn, run by The Hospital for Sick Children at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants with transient tachypnea of the newborn requiring non-invasive ventilation. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- nHFOV and nCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jul 2018
- 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 Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth between 34 and 42 weeks of gestation
- Admission to Bursa Yüksek Ihtisas Teaching Hospital, NICU during the first 24 hours of life
- Diagnosis of transient tachypnea of the newborn (TTN) within the first 24 hours of life
Who cannot join
- Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
- Chest X-ray or lung ultrasound finding indicating another respiratory disorder
- Additional infant diagnosis of major cardiac disease
- Additional infant diagnosis of major pulmonary disease other than TTN
- Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period
- Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Teaching Hospital
Bursa
About this study
Official title: Nasal High Frequency Oscillatory Ventilation Versus Nasal Continuous Positive Airway Pressure in Late-Preterm and Term Infants With Transient Tachypnea of the Newborn: a Randomized Controlled Trial
In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants with transient tachypnea of the newborn requiring non-invasive ventilation.
Read the detailed description
BACKGROUND: Non-invasive High Frequency Oscillatory Ventilation (nHFOV), aims to combine the efficacy of high frequency ventilation with the gentleness of non-invasive support and current evidence suggests that nHFOV may be superior to other non-invasive modes in terms of supporting alveolar ventilation. There are now several published neonatal studies of nHFOV therapy as a rescue mode even in the premature infants; however to date no studies have been published on the efficacy of nHFOV as a primary mode of non-invasive support. The investigators aim to assess the efficacy of nHFOV in late-preterm and term infants with transient tachypnea of the newborn as the primary mode of non-invasive support.
METHOD: The investigators propose to test the effectiveness of nHFOV in late-preterm and term neonates with transient tachypnea of the newborn (TTN) with a Silverman Score of 4 or above on admission who require non-invasive respiratory support. Nasal high frequency oscillatory ventilation may be effective in decreasing duration of non-invasive respiratory support and total oxygen therapy (H1 hypotheses).
The current literature estimates the incidence of transient tachypnea of the newborn to be 5.7 per 1000 births. Assuming that a 5% difference of the primary outcome between the groups is significant, when the alpha value is set at 0.05 and power of the study at 80%, 220 infants must be recruited for each arm (nCPAP and nHFOV) under investigation.
Chest X-ray, complete blood count, C-reactive protein and capillary blood gas analysis (as per unit protocol) will be obtained upon admission to the neonatal intensive care unit. A Silverman Score will be obtained for each participant upon admission and those with a score of 4 and above will be supported with one of the methods (with randomization).
Initial nHFOV settings are: MAP: 8cmH2O, Frequency:10 MHz, Amplitude:35 cmH2O (will be adjusted to achieve adequate chest wall vibration), I:E=1:1 and FiO2: adjusted to keep preductal sPO2 between %90-95. Initial nCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure of the primary mode is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O. When nCPAP or nHFOV failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. If the rescue mode fails, the infant will be intubated and conventional mechanical ventilation will be initiated.
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- nHFOV, nCPAP
- Keywords
- high frequency oscillatory ventilation, newborn, noninvasive ventilation, transient tachypnea of the newborn
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nHFOVDevice
Also called nasal high frequency oscillatory ventilation
Ventilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
nCPAPDevice
Also called nasal continuous positive airway pressure
Ventilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
| Study group | Role | What they receive |
|---|---|---|
| nHFOV | Experimental | Ventilator-derived nHFOV will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nHFOV settings are: MAP: 8cmH2O, Frequency:10 MHz, Amplitude:35 cmH2O (will be adjusted to achieve adequate chest wall vibration), I:E=1:1 and FiO2: adjusted to keep preductal sPO2 between %90-95.
Failure is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O.
When nHFOV failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. Receives: Device: nHFOV |
| nCPAP | Active comparator | Ventilator-derived nCPAP will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-95.
Failure is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O.
When nCPAP failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. Receives: Device: nCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cessation of non-invasive positive pressure respiratory support
Cessation of nasal flaring, grunting and chest wall retractions (Silverman Score of 0) are indicators of readiness for discontinuation non-invasive positive pressure respiratory support.
Measured: 72 hours
Secondary outcomes (2)
Time to cessation of supplemental oxygen
Total duration of oxygen support of >21%
Measured: 120 hours
Time to discharge from hospital
Discharge time
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transient Tachypnea of the NewbornStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Cizmeci, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mehmet N Cizmeci, M.D, Study director, Bursa Yuksek Ihtisas Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006354
- Sponsor's protocol ID
- 2011-KAEK-25 2016/22-06
- Status last verified
- Mar 2017
- First submitted
- 28 Dec 2016
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 25227281De Luca D, Dell'Orto V. Non-invasive high-frequency oscillatory ventilation in neonates: review of physiology, biology and clinical data. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F565-F570. doi: 10.1136/archdischild-2016-310664. Epub 2016 Jun 28.
PubMed 27354382Baldan E, Varal IG, Dogan P, Cizmeci MN. The effect of non-invasive high-frequency oscillatory ventilation on the duration of non-invasive respiratory support in late preterm and term infants with transient tachypnea of the newborn: a randomized controlled trial. Eur J Pediatr. 2023 Oct;182(10):4499-4507. doi: 10.1007/s00431-023-05128-4. Epub 2023 Jul 26.
PubMed 37491619
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Frequency Oscillatory Ventilation Versus Nasal Continuous Positive Airway Pressure in Late-Preterm and Term Infants With Transient Tachypnea of the Newborn: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03006354
- Acronym / sponsor ID
- 2011-KAEK-25 2016/22-06
- Conditions
- Transient Tachypnea of the Newborn
- Keywords
- high frequency oscillatory ventilation, newborn, noninvasive ventilation, transient tachypnea of the newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants with transient tachypnea of the newborn requiring non-invasive ventilation.
Detailed description
BACKGROUND: Non-invasive High Frequency Oscillatory Ventilation (nHFOV), aims to combine the efficacy of high frequency ventilation with the gentleness of non-invasive support and current evidence suggests that nHFOV may be superior to other non-invasive modes in terms of supporting alveolar ventilation. There are now several published neonatal studies of nHFOV therapy as a rescue mode even in the premature infants; however to date no studies have been published on the efficacy of nHFOV as a primary mode of non-invasive support. The investigators aim to assess the efficacy of nHFOV in late-preterm and term infants with transient tachypnea of the newborn as the primary mode of non-invasive support.
METHOD: The investigators propose to test the effectiveness of nHFOV in late-preterm and term neonates with transient tachypnea of the newborn (TTN) with a Silverman Score of 4 or above on admission who require non-invasive respiratory support. Nasal high frequency oscillatory ventilation may be effective in decreasing duration of non-invasive respiratory support and total oxygen therapy (H1 hypotheses).
The current literature estimates the incidence of transient tachypnea of the newborn to be 5.7 per 1000 births. Assuming that a 5% difference of the primary outcome between the groups is significant, when the alpha value is set at 0.05 and power of the study at 80%, 220 infants must be recruited for each arm (nCPAP and nHFOV) under investigation.
Chest X-ray, complete blood count, C-reactive protein and capillary blood gas analysis (as per unit protocol) will be obtained upon admission to the neonatal intensive care unit. A Silverman Score will be obtained for each participant upon admission and those with a score of 4 and above will be supported with one of the methods (with randomization).
Initial nHFOV settings are: MAP: 8cmH2O, Frequency:10 MHz, Amplitude:35 cmH2O (will be adjusted to achieve adequate chest wall vibration), I:E=1:1 and FiO2: adjusted to keep preductal sPO2 between %90-95. Initial nCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure of the primary mode is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O. When nCPAP or nHFOV failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. If the rescue mode fails, the infant will be intubated and conventional mechanical ventilation will be initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nHFOV | Experimental | Device: nHFOVVentilator-derived nHFOV will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nHFOV settings are: MAP: 8cmH2O, Frequency:10 MHz, Amplitude:35 cmH2O (will be adjusted to achieve adequate chest wall vibration), I:E=1:1 and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O. When nHFOV failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. |
| nCPAP | Active comparator | Device: nCPAPVentilator-derived nCPAP will be administered using binasal prongs. Standard Device: Leoni-Plus or Leoni-2 Ventilator, Heinen Löwenstein, Germany Initial nCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-95. Failure is defined as FiO2 requirement of >%60, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>65 cmH2O. When nCPAP failure occurs, nasal intermittent positive pressure ventilation (nIPPV) will be applied as a rescue therapy with the following settings: Frequency:30/min, PIP:18 cmH2O, PEEP:6 cmH2O, inspiration time:0.50 sec., inspiratory flow:10 L/min, FiO2:adjusted to keep preductal sPO2 between %90-95. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age at birth between 34 and 42 weeks of gestation
- Admission to Bursa Yüksek Ihtisas Teaching Hospital, NICU during the first 24 hours of life
- Diagnosis of transient tachypnea of the newborn (TTN) within the first 24 hours of life
Key exclusion criteria (6 listed)
- Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
- Chest X-ray or lung ultrasound finding indicating another respiratory disorder
- Additional infant diagnosis of major cardiac disease
- Additional infant diagnosis of major pulmonary disease other than TTN
- Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal 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 |
|---|---|---|
| nHFOVAlso: nasal high frequency oscillatory ventilationVentilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs | Device | nHFOV |
| nCPAPAlso: nasal continuous positive airway pressureVentilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs | Device | nCPAP |
Primary outcome
Time to cessation of non-invasive positive pressure respiratory support
Time frame: 72 hours
Cessation of nasal flaring, grunting and chest wall retractions (Silverman Score of 0) are indicators of readiness for discontinuation non-invasive positive pressure respiratory support.
2 secondary outcomes
Time to cessation of supplemental oxygen
Time frame: 120 hours
Time to discharge from hospital
Time frame: 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: 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.
- Results publication: PubMed 27354382De Luca D, Dell'Orto V. Non-invasive high-frequency oscillatory ventilation in neonates: review of physiology, biology and clinical data. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F565-F570. doi: 10.1136/archdischild-2016-310664. Epub 2016 Jun 28.
- Derived from this study: PubMed 37491619Baldan E, Varal IG, Dogan P, Cizmeci MN. The effect of non-invasive high-frequency oscillatory ventilation on the duration of non-invasive respiratory support in late preterm and term infants with transient tachypnea of the newborn: a randomized controlled trial. Eur J Pediatr. 2023 Oct;182(10):4499-4507. doi: 10.1007/s00431-023-05128-4. Epub 2023 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet N Cizmeci, M.D study director
Bursa Yuksek Ihtisas Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nHFOV and nCPAP in people with Transient Tachypnea of the Newborn, run by The Hospital for Sick Children at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to cessation of non-invasive positive pressure respiratory support (time frame: 72 hours). 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 NCT03006354, which also lists 3 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 6 Dec 2023.