NCT03006354

nHFOV Versus nCPAP in Transient Tachypnea of the Newborn

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	nHFOV	Ventilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
DEVICE	nCPAP	Ventilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-06-30
• Completion: 2018-07-01
• First posted: 2016-12-30
• Last updated: 2023-12-06

Locations

1 site across 1 country: Turkey (Türkiye)