NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
|ClinicalTrials.gov Identifier: NCT03099694|
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infants||Procedure: noninvasive high-frequency ventilation (nHFOV) Procedure: nasal continuous positive airway pressure (nCPAP)||Not Applicable|
Background: Invasive mechanical ventilation is associated with development of adverse pulmonary and non-pulmonary outcomes in very low birth weight infants. Various modes of non-invasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trials to compare the effect of noninvasive high-frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress syndrome (RDS) as a primary noninvasive ventilation support mode.
Methods/Design:In this multicenter, randomized, controlled trial, 300 preterm infants at gestational age (GA) less than 34 weeks with a diagnosis of RDS will be randomized to NHFOV or NCPAP as a primary mode of non-invasive respiratory support. Study will be conducted in 18 tertiary neonatal intensive care units in China.
The primary outcome is the need for invasive mechanical ventilation (IMV)during the first 7 days after enrollment in preterm infants randomized to the two groups. The secondary outcomes include days of hospitalization, days on noninvasive respiratory support, days on IMV, days on supplemental oxygen, mortality, need for surfactant, incidence of retinopathy of prematurity(ROP) and bronchopulmonary dysplasia(BPD), occurrence of abdominal distention, air leaks, intraventricular hemorrhage (IVH ≥ grade 3) and necrotizing enterocolitis (NEC> II stage). Other secondary outcomes include scores of Bayley Scales of Infant Development at 2 months and 2 years of corrected age.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial|
|Actual Study Start Date :||April 27, 2017|
|Actual Primary Completion Date :||July 28, 2018|
|Actual Study Completion Date :||July 28, 2018|
Active Comparator: nCPAP
nasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS
Procedure: nasal continuous positive airway pressure (nCPAP)
Infants assigned to the NCPAP group will be started on a pressure of 6 cmH2O (range: 6-8 cmH2O) by CPAP system (CNO Medin, Germany, Carefusion, USA)
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS
Procedure: noninvasive high-frequency ventilation (nHFOV)
NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.
- Number of Participants Who Required Intubation [ Time Frame: during the first 7 days after birth ]The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 > 60 mmHg with pH<7.20), severe apnea and bradycardia (defined as recurrent apnea with > 3 episodes per hour associated with heart rate < 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2>0.5 with PaO2<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue
- the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ) [ Time Frame: first two months after birth ]The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (≥ grade Ⅲ) is worse outcome.
- the Incidence of Pneumothorax [ Time Frame: during non-invasive ventilation, up to 7 days ]the incidence of pneumothorax
- the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II) [ Time Frame: during non-invasive ventilation, up to 7 days ]
The criteria for neonatal necrotizing enterocolitis(>stage II): Unequivocal malfunction of the gastrointestinal tract is demonstrated clinically and by radiographic evaluation. Other disorders such as malrotation and volvulus and Hirschsprung's disease must be excluded.
Neonatal necrotizing enterocolitis(>stage II) is worse outcome
- the Incidence of Retinopathy of Prematurity (>Stage II) [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous. Retinopathy of prematurity (>Stage II) is worse outcome.
- The Score of Bayley Scales of Infant Development [ Time Frame: 30 months ]scores of Bayley Scales of Infant Development at 2 months old and 2 years old
- the Incidence of Bronchopulmonary Dysplasia(BPD) [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]
BPD was defined according to the National Institutes of Health consensus definition: Need for O2 supplementation(FiO2>0.21) for at least 28 days after birth.
BPD is worse outcome.
- the Incidence of Abdominal Distention [ Time Frame: during non-invasive ventilation, up to 7 days ]Abdominal circumference increase 2 centimeter during non-invasive ventilation
- The Time of Non-invasive Ventilation [ Time Frame: during non-invasive ventilation, up to 30 days ]Hours
- Length of Hospitalization [ Time Frame: during hospitalization, up to 60 days ]Days
- Predischarge Mortality [ Time Frame: during hospitalization, up to 60 days ]
- Length of O2 Therapy [ Time Frame: during hospitalization, up to 60 days ]Days
- Number of Participants With Thick Secretions Causing an Airway Obstruction [ Time Frame: during non-invasive ventilation, up to 15 days ]determined by the clinician
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099694
|Chongqing, Chongqing, China, 400000|
|Study Director:||Shi Yuan, PhD||Third Military Medical University|