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| Name | Class |
|---|---|
| Guiyang Maternity and Child Health Care Hospital | OTHER |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| Children's Hospital of Chongqing Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCPAP | Active Comparator | nasal continuous positive airway pressure (nCPAP) - as a primary mode of ventilation in premature infants with RDS |
|
| nHFOV | Experimental | noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in premature infants with RDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | first two months after birth |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Shi Yuan, PhD | Third Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingwang Zhu | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33827081 | Derived | 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. | |
| 29898763 | Derived |
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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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1045 Did not undergo randomization
From May, 2017, through July, 2018, a total of 18 centers screened 2509 infants, of which 1385 were eligible. We recruited 340 infants (170 in each group), to account for dropouts. Finally, 302 infants completed the trial (152 in NHFOV; 150 in NCPAP group.)
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| ID | Title | Description |
|---|---|---|
| FG000 | nCPAP | infants receive primary non-invasive respiratory support by mean of nCPAP |
| FG001 | nHFOV | infants receive primary non-invasive respiratory support by mean of NHFOV |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | nCPAP | infants receive primary non-invasive respiratory support by mean of nCPAP |
| BG001 | nHFOV | infants receive primary non-invasive respiratory support by mean of NIPPV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | during the first 7 days after birth |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | nHFOV | infants receive primary non-invasive respiratory support by mean of nHFOV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Shi Yuan | Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, Key Laboratory of Pediatrics in Chongqing | 13508300283 | 15084335697@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2017 | Feb 23, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2017 | Feb 23, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Chongqing Maternal and Child Health Hospital | OTHER |
| The Second Hospital of Shandong University | OTHER |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Zhengzhou Children's Hospital, China | OTHER |
| Chengdu Women's and Children's Central Hospital | OTHER |
| The People's Hospital of Dehong Autonomous Prefecture | OTHER |
| Kunming Children's Hospital | OTHER |
| Chongqing Three Gorges Central Hospital | OTHER |
| Shanxi Provincial Maternity and Children's Hospital | OTHER |
| University of Southern California | OTHER |
| Vilnius University | OTHER |
| Children's Hospital of Fudan University | OTHER |
| Guangdong Women and Children Hospital | OTHER |
| Nanjing Children's Hospital | OTHER |
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| 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) |
|
| the Incidence of Pneumothorax |
the incidence of pneumothorax |
| 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 | 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. | at a post-menstrual age of 36 weeks or at discharge |
| 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 |
| 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 |
| the Incidence of Abdominal Distention | Abdominal circumference increase 2 centimeter during non-invasive ventilation | during non-invasive ventilation, up to 7 days |
| The Time of Non-invasive Ventilation | Hours | during non-invasive ventilation, up to 30 days |
| Length of Hospitalization | Days | during hospitalization, up to 60 days |
| Predischarge Mortality | during hospitalization, up to 60 days |
| Length of O2 Therapy | Days | during hospitalization, up to 60 days |
| Number of Participants With Thick Secretions Causing an Airway Obstruction | determined by the clinician | during non-invasive ventilation, up to 15 days |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Multiple birth | Mothers of infants | Count of Participants | Participants |
|
| Antenatal steroids | Mothers of infants | Count of Participants | Participants |
|
| Cesarean delivery | Mothers of infants | Count of Participants | Participants |
|
| Premature rupture of membranes>18h | Mothers of infants | Count of Participants | Participants |
|
| Gestational diabetes mellitus | Mothers of infants | Count of Participants | Participants |
|
| Birth Weight | Mean | Standard Deviation | g |
|
infants receive primary non-invasive respiratory support by mean of NHFOV |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | first two months after birth |
|
|
|
| Secondary | the Incidence of Pneumothorax | the incidence of pneumothorax | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Not Posted | Sep 2021 | 30 months | Participants |
| 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | during non-invasive ventilation, up to 7 days |
|
|
|
| Secondary | The Time of Non-invasive Ventilation | Hours | Posted | Median | Inter-Quartile Range | hours | during non-invasive ventilation, up to 30 days |
|
|
|
| Secondary | Length of Hospitalization | Days | Posted | Median | Inter-Quartile Range | days | during hospitalization, up to 60 days |
|
|
|
| Secondary | Predischarge Mortality | Posted | Count of Participants | Participants | during hospitalization, up to 60 days |
|
|
|
| Secondary | Length of O2 Therapy | Days | Posted | Median | Inter-Quartile Range | days | during hospitalization, up to 60 days |
|
|
|
| Secondary | Number of Participants With Thick Secretions Causing an Airway Obstruction | determined by the clinician | Posted | Count of Participants | Participants | during non-invasive ventilation, up to 15 days |
|
|
|
| 6 |
| 152 |
| 0 |
| 152 |
| 0 |
| 152 |
| EG001 | nCPAP | infants receive primary non-invasive respiratory support by mean of nCPAP | 4 | 150 | 0 | 150 | 0 | 150 |
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| D012138 |
| Respiratory Therapy |