Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome (NHFOV)

Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Randomized Controlled Trial

In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key cornerstone to reduce neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key procedure to reducing these risks above, and if extubation does not success, repeated intubation and/or prolonged duration of IV will result in increased medical burden and intubation-associated complications and death. How to minimize the need for endotracheal ventilation and subsequent complications constitutes a challenge for neonatologists.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Preterm Infant
• Intervention / Treatment: Device: NHFOV; Device: NCPAP

Detailed Description

Early weaning from invasive ventilation and avoiding re-intubation remains a focus. Nowadays, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. NCPAP is a widely used way of noninvasive ventilation strategies in preterm infants. However, there is only 60% success rate in avoiding intubation. Supplying with the combined advantages of HFOV and NCPAP with high CO2 removal, no need for synchronisation, less volume/barotraumas, non-invasion and increased functional residual capacity, nasal high frequency oscillation ventilation (NHFOV) is considered as a strengthened version of NCPAP. Thus, NHFOV may be more effective as post-extubation respiratory support to avoid re-intubation and subsequent complications/sequelae comparing with NCPAP in preterm infants. To date, NHFOV was used increasingly in neonatal intensive care unit (NICU) around the world due to its convenient operation and no consideration of synchronisation, and several small studies have reported the beneficial effects of NHFOV in preterm infants. However, there were rare randomized controlled studies compared NHFOV with NCPAP as post-extubation respiratory support strategies in preterm infants.

The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support on the need for endotracheal ventilation and subsequent complications in preterm infants.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The gestational age was less than 37 weeks;
• These neonates were diagnosed with RDS and supported by invasive ventilation with synchronized intermittent mandatory ventilation (SIMV. The diagnosis of RDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of RDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung;
• The neonates were ready to be extubated for the first time and subsequent noninvasive ventilation.

Exclusion Criteria:

• parents' decision not to participate;
• major congenital anomalies;
• died or left the NICU within 24 hour.

Eligibility criteria for extubation:

Besides the improved symptoms, X-rays and sufficient spontaneous breathing efforts, the eligibility criteria for extubation were peak inspiratory pressure (PIP) of 15-20 cm H2O, positive end expiratory pressure (PEEP) of 4-6 cm H2O, respiratory rate of 15 to 30, FiO2 from 0.21 to 0.30, hematocrit more than 35%. and arterialized capillary blood gas analysis need to meet the following criteria: pH>7.20, PaCO2<=55 mmHg.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NHFOV; NHFOV is used as the supporting mode after extubation	Device: NHFOV; NHFOV is used as the noninvasive mode after extubation
Active Comparator: NCPAP; NCPAP is used as the supporting mode after extubation	Device: NCPAP; NCPAP is used as the noninvasive mode after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation rate	the baby was re-intubated due to respiratory failure	3 days
total time of hospitalization	the duration of baby in hospital	100 days
bronchopulmonary dysplasia(BPD)	bronchopulmonary dysplasia was diagnosed after extubation BPD was defined according to the National Institutes of Health consensus definition	at 28 days after birth or 36 weeks'gestational age or at discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airleaks	airleaks was diagnosed after extubation	3 days
Retinopathy of prematurity	Retinopathy of prematurity was diagnosed after extubation	100 days
Neonatal necrotizing enterocolitis	Neonatal necrotizing enterocolitis was diagnosed after extubation	3 days
Intraventricular hemorrhage	Intraventricular hemorrhage was diagnosed after extubation	3 days
mortality rate	the baby died in hospital	100 days
patent ductus arteriosus (PDA)	patent ductus arteriosus (PDA) was diagnosed	100 days

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Publications and helpful links

General Publications

• Chen L, Wang L, Ma J, Feng Z, Li J, Shi Y. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants With Respiratory Distress Syndrome and ARDS After Extubation: A Randomized Controlled Trial. Chest. 2019 Apr;155(4):740-748. doi: 10.1016/j.chest.2019.01.014.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: preterm infant; respiratory distress syndrome; nasal high frequence oscillation ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: NHFOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

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