NHFOV as Primary Support in Very Preterm Infants With RDS
Primary Purpose
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infants receive primary non-invasive respiratory support by mean of nCPAP
infants receive primary non-invasive respiratory support by mean of NHFOV
Sponsored by
About this trial
This is an interventional treatment trial for to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates focused on measuring nasal high frequency oscillation ventilation(NHFOV); nasal continuous positive airway pressure(NCPAP); preterm infants
Eligibility Criteria
Inclusion Criteria:
- Gestational age (GA) of less than 29 weeks Clinical diagnose of RDS and Oxygenation index(OI=(FiO2×Paw)×100/PaO2) more than 2 Age less than 2 hours
Exclusion Criteria:
Intubated forany reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Sites / Locations
- Hunan Provincial Maternal and Child Health Care HospitalRecruiting
- The Second Hospital of Shandong UniversityRecruiting
- Qujing Maternity and cChild Healthcare HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NCPAP
NHFOV
Arm Description
Outcomes
Primary Outcome Measures
treatment failure within 72 hours after randomization 72 hours after randomization need for invasive mechanical ventilation
Secondary Outcome Measures
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
the diagnosis a Chest XR
Full Information
NCT ID
NCT05141435
First Posted
November 19, 2021
Last Updated
January 12, 2023
Sponsor
Jiulongpo No.1 People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05141435
Brief Title
NHFOV as Primary Support in Very Preterm Infants With RDS
Official Title
NHFOV vs nCPAP in Very Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiulongpo No.1 People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (NIV) mode.
Detailed Description
Preterm infants are eligible to the study if they they match the following inclusion criteria: (1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%;; (3) Age less than 2 hours; (4)Informed parental consent has been obtained.
Neonates will be randomized and assigned either to nCPAP or NHFOV arms with a 1:1ratio, when patients fulfill all inclusion criteria. Randomization cannot be done earlier. Simple randomization will be done according to a computer-generated random number table and will be posted in a specific secured website 24/7 available. Twins will be allocated in the same treatment group. Infants randomized to one arm cannot crossover to the other or vice- versa during the study. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 per target SpO2 89-94% after starting the respiratory support, newborns receive Surfactant by "LISA" technique, administration of surfactant (Curosurf,Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg.
After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2 89-94% or severe apnea episodes are present (defined as recurrent apnea with >3 episodes/h associated with heart rate <100/min or a single episode of apnea requiring bag and mask ventilation within a 24-hour period ) or at the blood gas (arterial or free-flowing capillary blood) PaCO2>60 mmHg and potential of hydrogen (pH)<7.20 obtained at least 1 hour after commencement of the assigned treatment, newborns are intubated and mechanically ventilated.
For all the newborns enrolled in the study, arterial or free-flowing capillary blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
Keywords
nasal high frequency oscillation ventilation(NHFOV); nasal continuous positive airway pressure(NCPAP); preterm infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Title
NHFOV
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
infants receive primary non-invasive respiratory support by mean of nCPAP
Intervention Description
neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.
Intervention Type
Procedure
Intervention Name(s)
infants receive primary non-invasive respiratory support by mean of NHFOV
Intervention Description
neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).
Primary Outcome Measure Information:
Title
treatment failure within 72 hours after randomization 72 hours after randomization need for invasive mechanical ventilation
Time Frame
within 72 hrs from the beginning of the study mode
Secondary Outcome Measure Information:
Title
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
Description
the diagnosis a Chest XR
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Other Pre-specified Outcome Measures:
Title
Rate of bronchopulmonary dysplasia
Description
defined according to the NICHD definition
Time Frame
36 weeks of postmenstrual age
Title
Rate of retinopathy of prematurity (ROP) ≥ 2nd stage
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
Rate of necrotizing enterocolitis (NEC) ≥ 2nd stage
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
Rate of intraventricular hemorrhage ≥ 3nd grade
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
Rate of thick secretions causing an airway obstruction
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
in-hospital mortality
Time Frame
through study completion, an average of 1 year
Title
Rate of nasal trauma
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
composite mortality/BPD tality/BPD
Time Frame
through study completion, an average of 1 year
Title
weekly weight gain
Description
in grams/d
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
overall duration of non invasive respiratory assistance
Time Frame
the first 4weeks of life or until NICU discharge, whichever comes first
Title
Surfactant treatment
Description
the overall number of doses of surfactant are considered
Time Frame
within 72 hrs from the beginning of the study mode
Title
overall duration of hospitalisation
Time Frame
up to 2 years from birth
Title
Patent Doctus Arterious
Description
If a pharmaceutical or surgical treatment is required is considered. Small doctuses closing spontaneously during the first days of life are not included.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%;(3) Age less than 2 hours
Exclusion Criteria:
Intubated forany reasons at birth
Major congenital malformations or known complex congenital heart disease
No parental consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingwang Zhu, MD
Phone
+86150843335697
Email
15084335697@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Shi, PhD
Phone
+8613508300283
Email
shiyuan@hospital.cqmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shi, PhD
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Hunan Provincial Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Li, MD
Email
It690880060@icloud.com
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Zhu, MD
Email
201262015319@email.sdu.edu.cn
Facility Name
Qujing Maternity and cChild Healthcare Hospital
City
Qujing
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanfeng Li, MD
Email
qjfyxselcf@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing URL
http://nasone.rxdemo.cn/admin/login/login
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NHFOV as Primary Support in Very Preterm Infants With RDS
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