NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial
1 other identifier
interventional
340
1 country
1
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．
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2018
CompletedResults Posted
Study results publicly available
June 10, 2019
CompletedMarch 2, 2021
February 1, 2021
1.3 years
November 17, 2016
October 7, 2018
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)
first two months after birth
the Incidence of Pneumothorax
during non-invasive ventilation, up to 7 days
the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)
during non-invasive ventilation, up to 7 days
the Incidence of Retinopathy of Prematurity (>Stage II)
at a post-menstrual age of 36 weeks or at discharge
The Score of Bayley Scales of Infant Development
30 months
- +7 more secondary outcomes
Study Arms (2)
nCPAP
ACTIVE COMPARATORnasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS
nHFOV
EXPERIMENTALnoninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS
Interventions
NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.
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 Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xingwang Zhulead
- Guiyang Maternity and Child Health Care Hospitalcollaborator
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical Universitycollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Chongqing Maternal and Child Health Hospitalcollaborator
- The Second Hospital of Shandong Universitycollaborator
- Yan'an Affiliated Hospital of Kunming Medical Universitycollaborator
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
- Hunan Children's Hospitalcollaborator
- Zhengzhou Children's Hospital, Chinacollaborator
- Chengdu Women's and Children's Central Hospitalcollaborator
- The People's Hospital of Dehong Autonomous Prefecturecollaborator
- Kunming Children's Hospitalcollaborator
- Chongqing Three Gorges Central Hospitalcollaborator
- Shanxi Provincial Maternity and Children's Hospitalcollaborator
- University of Southern Californiacollaborator
- Vilnius Universitycollaborator
- Children's Hospital of Fudan Universitycollaborator
- Guangdong Women and Children Hospitalcollaborator
- Nanjing Children's Hospitalcollaborator
Study Sites (1)
Xingwang Zhu
Chongqing, Chongqing Municipality, 400000, China
Related Publications (2)
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.
PMID: 33827081DERIVEDZhu 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.
PMID: 29898763DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Shi Yuan
- Organization
- Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, Key Laboratory of Pediatrics in Chongqing
Study Officials
- STUDY DIRECTOR
Shi Yuan, PhD
Third Military Medical University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of neonatology
Study Record Dates
First Submitted
November 17, 2016
First Posted
April 4, 2017
Study Start
April 27, 2017
Primary Completion
July 28, 2018
Study Completion
July 28, 2018
Last Updated
March 2, 2021
Results First Posted
June 10, 2019
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
Dr. Kris Sekar, Professor of Pediatrics, Oklahoma University Medical Center, Oklahoma, Dr. Jatinder Bhatia, Professor of Pediatrics, Medical College of Georgia, Georgia Health Sciences University, Augusta, Georgia, and Dr. Rowena Cayabyab, MD., MPH (Biostatistics and Epidemiology) Assistant Professor of Pediatrics, Keck School of Medicine of the University of Southern California, Los Angeles, California will serve as DSMB members. Dr. Cayabyab will also serve as consultant for statistical analysis.