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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099694
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
Guiyang Maternity and Child Health Care Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital
The Second Hospital of Shandong University
Yan'an Affiliated Hospital of Kunming Medical University
The Children's Hospital of Zhejiang University School of Medicine
Hunan Children's Hospital
Zhengzhou Children's Hospital, China
Chengdu Women's and Children's Central Hospital
The People's Hospital of Dehong Autonomous Prefecture
Kunming Children's Hospital
Chongqing Three Gorges Central Hospital
Shanxi Provincial Maternity and Children's Hospital
University of Southern California
Vilnius University
Children's Hospital of Fudan University
Guangdong Women and Children Hospital
Nanjing Children's Hospital
Information provided by (Responsible Party):
Xingwang Zhu, Jiulongpo No.1 People's Hospital

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.

Condition or disease Intervention/treatment Phase
Preterm Infants Procedure: noninvasive high-frequency ventilation (nHFOV) Procedure: nasal continuous positive airway pressure (nCPAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : July 28, 2018
Actual Study Completion Date : July 28, 2018


Arm Intervention/treatment
Active Comparator: nCPAP
nasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS
Procedure: 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)

Experimental: nHFOV
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS
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.




Primary Outcome Measures :
  1. Number of Participants Who Required Intubation [ Time Frame: 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 :
  1. the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ) [ Time Frame: 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.

  2. the Incidence of Pneumothorax [ Time Frame: during non-invasive ventilation, up to 7 days ]
    the incidence of pneumothorax

  3. the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II) [ Time Frame: 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


  4. the Incidence of Retinopathy of Prematurity (>Stage II) [ Time Frame: 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.

  5. The Score of Bayley Scales of Infant Development [ Time Frame: 30 months ]
    scores of Bayley Scales of Infant Development at 2 months old and 2 years old

  6. the Incidence of Bronchopulmonary Dysplasia(BPD) [ Time Frame: 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.


  7. the Incidence of Abdominal Distention [ Time Frame: during non-invasive ventilation, up to 7 days ]
    Abdominal circumference increase 2 centimeter during non-invasive ventilation

  8. The Time of Non-invasive Ventilation [ Time Frame: during non-invasive ventilation, up to 30 days ]
    Hours

  9. Length of Hospitalization [ Time Frame: during hospitalization, up to 60 days ]
    Days

  10. Predischarge Mortality [ Time Frame: during hospitalization, up to 60 days ]
  11. Length of O2 Therapy [ Time Frame: during hospitalization, up to 60 days ]
    Days

  12. Number of Participants With Thick Secretions Causing an Airway Obstruction [ Time Frame: during non-invasive ventilation, up to 15 days ]
    determined by the clinician



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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099694


Locations
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China, Chongqing
Xingwang Zhu
Chongqing, Chongqing, China, 400000
Sponsors and Collaborators
Xingwang Zhu
Guiyang Maternity and Child Health Care Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital
The Second Hospital of Shandong University
Yan'an Affiliated Hospital of Kunming Medical University
The Children's Hospital of Zhejiang University School of Medicine
Hunan Children's Hospital
Zhengzhou Children's Hospital, China
Chengdu Women's and Children's Central Hospital
The People's Hospital of Dehong Autonomous Prefecture
Kunming Children's Hospital
Chongqing Three Gorges Central Hospital
Shanxi Provincial Maternity and Children's Hospital
University of Southern California
Vilnius University
Children's Hospital of Fudan University
Guangdong Women and Children Hospital
Nanjing Children's Hospital
Investigators
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Study Director: Shi Yuan, PhD Third Military Medical University
  Study Documents (Full-Text)

Documents provided by Xingwang Zhu, Jiulongpo No.1 People's Hospital:
Informed Consent Form  [PDF] July 13, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xingwang Zhu, Director of neonatology, Jiulongpo No.1 People's Hospital
ClinicalTrials.gov Identifier: NCT03099694    
Other Study ID Numbers: Jiulongpo People's Hospital
First Posted: April 4, 2017    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xingwang Zhu, Jiulongpo No.1 People's Hospital:
NRDS
nHFOV
nCPAP
preterm infants
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases