Nasal High Frequency in Preterm Neonates

Non-Invasive High Frequency Oscillatory Ventilation Versus Continuous Positive Airway Pressure in Preterm Neonates with Respiratory Distress Syndrome

One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. The application of nasal high-frequency ventilation with the strategy of lung recruitment will combine benefits of improving gas exchange and decreasing lung injury together with avoiding complication of invasive ventilation.

Study Overview

• Status: Completed
• Conditions: Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome (RDS)
• Intervention / Treatment: Device: nasal high frequency oscillatory ventilation mode; Drug: nasal continuous positive pressure ventilation mode

Detailed Description

Premature infants with respiratory distress syndrome (RDS) usually require respiratory support . Due to the complications of intubation and mechanical ventilation, in the last decade, attempts have been made to use non-invasive methods in the management of these patients . Over the past few decades, nasal ventilation has been used to control and improve respiratory failure in infants with RDS . nCPAP is a relatively simple and effective therapy in the early management of RDS in newborns . nCPAP is the application of positive pressure to the airways of spontaneously breathing neonates throughout the respiratory cycle . However, some neonates with this therapeutic approach also develop respiratory failure and need mechanical ventilatory support. According to some investigations, 43%-80% of infants with moderate to severe respiratory failure who are initially treated with nCPAP need mechanical ventilation .

In recent years, the beneficial effects of high-frequency ventilators (HFV) have been shown in the management of RDS as well as the use of this mode as the initial mode of support or as a rescue treatment after failure of conventional mechanical ventilation. In high-frequency ventilation, a low tidal volume with a higher frequency than that of physiological respiration is produced. This technique is very effective in eliminating carbon dioxide (CO2). Adequate recruitment of lung volume in this mechanical mode has the main role of protecting and preserving lung architecture as well as potentiating surfactant therapy.

The nHFOV is a non-invasive ventilation mode that applies an oscillatory pressure waveform to the airways using a nasal interface. nHFOV is effective and superior to nasal intermittent positive pressure ventilation in terms of lung CO2 elimination. This mode has been shown to facilitate CO2 elimination, but little is known about its use in neonates. There is increasing evidence of beneficial effects of nHFOV in reducing the duration of ventilator support compared with the effects of nCPAP in RDS. We intended to explore the benefits of nHFOV vs nCPAP in preterm neonates.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gestational age: 30-34 weeks (determined by date of last menstrual period or ultrasound) and confirmed by Ballard score.
• Recruited immediately after birth Up to 24 hours of age.
• Appropriate weight for the gestational age.
• Spontaneous breathing and clinical signs and symptoms of respiratory distress syndrome (grunting, cyanosis, intercostal and subcostal retractions) or RDS Silverman Score > 5.

Exclusion Criteria:

• Major congenital abnormalities, congenital heart disease and diaphragmatic hernia.
• A need for intubation and mandatory ventilation during resuscitation or on the first day of life.
• Perinatal asphyxia (Umbilical cord pH < 7.16, and umbilical cord bicarbonate < 12 mEq/L)
• Pulmonary hemorrhage and severe intraventricular hemorrhage (IVH) on admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nasal high frequency; Preterm neonates who will be allocated will start nHFOV. nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart. The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter	Device: nasal high frequency oscillatory ventilation mode; Preterm neonates who will be allocated will start nHFOV: (CNO, Medin, Germany). nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart; Medin, Germany). The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.
Active Comparator: nasal CPAP; Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.	Drug: nasal continuous positive pressure ventilation mode; Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
need for invasive mechanical ventilation	five days

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	one month
duration of respiratory support	one month

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Diblasi RM. Nasal continuous positive airway pressure (CPAP) for the respiratory care of the newborn infant. Respir Care. 2009 Sep;54(9):1209-35.
• Aktas S, Unal S, Aksu M, Ozcan E, Ergenekon E, Turkyilmaz C, Hirfanoglu I, Atalay Y. Nasal HFOV with Binasal Cannula Appears Effective and Feasible in ELBW Newborns. J Trop Pediatr. 2016 Apr;62(2):165-8. doi: 10.1093/tropej/fmv088. Epub 2015 Dec 27.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: respiratory distress; non invasive ventilation; preterm neonate; high frequency ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Infant, Newborn, Diseases
• Other Study ID Numbers: nasal high frequency neonates

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data can be shared upon accepted reasons
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No