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

Xingwang Zhu340 enrolled

Overview

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．

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

Preterm Infants

Interventions

noninvasive high-frequency ventilation (nHFOV)PROCEDURE

NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.

nasal continuous positive airway pressure (nCPAP)PROCEDURE

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)

Eligibility

Sex: ALLMax age: 12 Hours

Medical Language ↔ Plain English

Inclusion criteria: (1)Gestational age (GA) is from 26 to 34 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; (3) RDS Silverman score\>5; (4) informed parental consent has been obtained. Exclusion criteria (1) severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; (2)major congenital malformations or complex congenital heart disease; (3) group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; (4) cardiopulmonary arrest needing prolonged resuscitation; (5) transferred out of the NICUs without treatment.

Locations (1)

Xingwang Zhu

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Number of Participants Who Required Intubation

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

Time frame: during the first 7 days after birth

Secondary Outcomes

the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)

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.

Time frame: first two months after birth

the Incidence of Pneumothorax

the incidence of pneumothorax

Time frame: during non-invasive ventilation, up to 7 days

the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)

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

Time frame: during non-invasive ventilation, up to 7 days

the Incidence of Retinopathy of Prematurity (>Stage II)

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.

Data from ClinicalTrials.gov

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