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

Preterm Infants Clinical Trial

Official title:

Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099694
• Other study ID #: Jiulongpo People's Hospital
• Status: Completed
• Phase: N/A
• Start date: April 27, 2017
• Est. completion date: July 28, 2018

Study information

• Verified date: February 2021
• Source: Jiulongpo No.1 People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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．

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 information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: July 28, 2018
• Est. primary completion date: July 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• 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)

Locations

Country	Name	City	State
China	Xingwang Zhu	Chongqing	Chongqing

Sponsors (20)

Lead Sponsor

Collaborator

Xingwang Zhu

Chengdu Women's and Children's Central Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, Chongqing Maternal and Child Health Hospital, Chongqing Three Gorges Central Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Guangdong Women and Children Hospital, Guiyang Maternity and Child Health Care Hospital, Hunan Children's Hospital, Kunming Children's Hospital, Nanjing Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, The People's Hospital of Dehong Autonomous Prefecture, The Second Hospital of Shandong University, University of Southern California, Vilnius University, Yan'an Affiliated Hospital of Kunming Medical University, Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during the first 7 days after birth
Secondary	the Incidence of Intraventricular Hemorrhage (IVH, = Grade ?)	The criteria for intraventricular hemorrhage (IVH, = grade ?): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (= grade ?) is worse outcome.	first two months after birth
Secondary	the Incidence of Pneumothorax	the incidence of pneumothorax	during non-invasive ventilation, up to 7 days
Secondary	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	during non-invasive ventilation, up to 7 days
Secondary	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.	at a post-menstrual age of 36 weeks or at discharge
Secondary	The Score of Bayley Scales of Infant Development	scores of Bayley Scales of Infant Development at 2 months old and 2 years old	30 months
Secondary	the Incidence of Bronchopulmonary Dysplasia(BPD)	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.	at a post-menstrual age of 36 weeks or at discharge
Secondary	the Incidence of Abdominal Distention	Abdominal circumference increase 2 centimeter during non-invasive ventilation	during non-invasive ventilation, up to 7 days
Secondary	The Time of Non-invasive Ventilation	Hours	during non-invasive ventilation, up to 30 days
Secondary	Length of Hospitalization	Days	during hospitalization, up to 60 days
Secondary	Predischarge Mortality		during hospitalization, up to 60 days
Secondary	Length of O2 Therapy	Days	during hospitalization, up to 60 days
Secondary	Number of Participants With Thick Secretions Causing an Airway Obstruction	determined by the clinician	during non-invasive ventilation, up to 15 days