Clinical trial NCT03099694: NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Official title: Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: NRDS
nHFOV
nCPAP
preterm infants
Lead sponsor: Jiulongpo No.1 People's Hospital
Sponsor class: OTHER
Collaborators: name: Guiyang Maternity and Child Health Care Hospital
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Children's Hospital of Chongqing Medical University
name: Chongqing Maternal and Child Health Hospital
name: The Second Hospital of Shandong University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: The Children's Hospital of Zhejiang University School of Medicine
name: Hunan Children's Hospital
name: Zhengzhou Children's Hospital, China
name: Chengdu Women's and Children's Central Hospital
name: The People's Hospital of Dehong Autonomous Prefecture
name: Kunming Children's Hospital
name: Chongqing Three Gorges Central Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: University of Southern California
name: Vilnius University
name: Children's Hospital of Fudan University
name: Guangdong Women and Children Hospital
name: Nanjing Children's Hospital
First posted: 2017-04-04
Enrollment: 340
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Required Intubation
timeFrame: during the first 7 days after birth
Secondary outcomes:
measure: the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
timeFrame: first two months after birth
measure: the Incidence of Pneumothorax
timeFrame: during non-invasive ventilation, up to 7 days
measure: the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)
timeFrame: during non-invasive ventilation, up to 7 days
measure: the Incidence of Retinopathy of Prematurity (>Stage II)
timeFrame: at a post-menstrual age of 36 weeks or at discharge
measure: The Score of Bayley Scales of Infant Development
timeFrame: 30 months
measure: the Incidence of Bronchopulmonary Dysplasia(BPD)
timeFrame: at a post-menstrual age of 36 weeks or at discharge
measure: the Incidence of Abdominal Distention
timeFrame: during non-invasive ventilation, up to 7 days
measure: The Time of Non-invasive Ventilation
timeFrame: during non-invasive ventilation, up to 30 days
measure: Length of Hospitalization
timeFrame: during hospitalization, up to 60 days
measure: Predischarge Mortality
timeFrame: during hospitalization, up to 60 days
measure: Length of O2 Therapy
timeFrame: during hospitalization, up to 60 days
measure: Number of Participants With Thick Secretions Causing an Airway Obstruction
timeFrame: during non-invasive ventilation, up to 15 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xingwang Zhu
state: Chongqing
Study officials:
affiliation: Third Military Medical University
name: Shi Yuan, PhD
role: STUDY_DIRECTOR
References:
citation: Zhu X, Feng Z, Liu C, Shi L, Shi Y, Ramanathan R; NHFOV study group. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial. Neonatology. 2021;118(3):325-331. doi: 10.1159/000515226. Epub 2021 Apr 7.
citation: Zhu XW, Shi Y, Shi LP, Liu L, Xue J, Ramanathan R; NHFOV Study Group. Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial. Trials. 2018 Jun 14;19(1):319. doi: 10.1186/s13063-018-2673-9.