NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)

Not Applicable

Completed

Conditions: Preterm Infants

Interventions: Procedure: nasal continuous positive airway pressure (nCPAP)
Procedure: noninvasive high-frequency ventilation (nHFOV)

Registration Number: NCT03099694

Lead Sponsor: Xingwang Zhu

Brief Summary: The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in premature infants with RDS．

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nCPAP	nasal continuous positive airway pressure (nCPAP)	nasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS
nHFOV	noninvasive high-frequency ventilation (nHFOV)	noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Required Intubation	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

Secondary Outcome Measures

Name	Time	Method
the Incidence of Bronchopulmonary Dysplasia(BPD)	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.
Length of Hospitalization	during hospitalization, up to 60 days	Days
Number of Participants With Thick Secretions Causing an Airway Obstruction	during non-invasive ventilation, up to 15 days	determined by the clinician
the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)	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 Neonatal Necrotizing Enterocolitis(>Stage II)	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 Score of Bayley Scales of Infant Development	30 months	scores of Bayley Scales of Infant Development at 2 months old and 2 years old
the Incidence of Abdominal Distention	during non-invasive ventilation, up to 7 days	Abdominal circumference increase 2 centimeter during non-invasive ventilation
the Incidence of Pneumothorax	during non-invasive ventilation, up to 7 days	the incidence of pneumothorax
The Time of Non-invasive Ventilation	during non-invasive ventilation, up to 30 days	Hours
Length of O2 Therapy	during hospitalization, up to 60 days	Days
the Incidence of Retinopathy of Prematurity (>Stage II)	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.
Predischarge Mortality	during hospitalization, up to 60 days