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

NCT03140891 | Completed DMC

• 1 other identifier: NHFOV
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome; Preterm Infant

Keywords

preterm infant; respiratory distress syndrome; nasal high frequence oscillation ventilation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• airleaks

  3 days

• Retinopathy of prematurity

  100 days

• Neonatal necrotizing enterocolitis

  3 days

• Intraventricular hemorrhage

  3 days

• mortality rate

  100 days

Study Arms (2)

NHFOV

EXPERIMENTAL

NHFOV is used as the supporting mode after extubation

Device: NHFOV

NCPAP

ACTIVE COMPARATOR

NCPAP is used as the supporting mode after extubation

Device: NCPAP

Interventions

NHFOV DEVICE

NHFOV is used as the noninvasive mode after extubation

NHFOV

NCPAP DEVICE

NCPAP is used as the noninvasive mode after extubation

NCPAP

Eligibility Criteria

• Age: 30 Minutes - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• 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.

  PMID: 30955572 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Shi Yuan, PhD,MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 4, 2017
• Study Start: April 15, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 15, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)