nHFOV Versus nCPAP in Transient Tachypnea of the Newborn

November 29, 2023 updated by: Mehmet Cizmeci, The Hospital for Sick Children

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bursa, Turkey
        • University of Health Sciences, Bursa Yuksek Ihtisas Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nHFOV

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.

Ventilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
Other Names:
  • nasal high frequency oscillatory ventilation
Active Comparator: nCPAP

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.

Ventilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
Other Names:
  • nasal continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to cessation of supplemental oxygen
Time Frame: 120 hours
Total duration of oxygen support of >21%
120 hours
Time to discharge from hospital
Time Frame: 120 hours
Discharge time
120 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumothorax
Time Frame: 72 hours
Number of pneumothoraces requiring tube thoracostomy in each group
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mehmet N Cizmeci, M.D, Bursa Yuksek Ihtisas Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimated)

December 30, 2016

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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