Clinical trial NCT05141435: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Jiulongpo No.1 People's Hospital
Sponsor class: OTHER
Collaborators: name: Jiangxi Maternal and Child Health Hospital
name: Children's Hospital of Chongqing Medical University
name: Guiyang Maternity and Child Health Care Hospital
name: The Second Hospital of Shandong University
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Women and Children's Health Hospital of Yulin
name: Chongqing Three Gorges Central Hospital
name: Gansu Provincial Maternal and Child Health Care Hospital
name: The First People's Hospital of Yunnan
name: Chengdu Women's and Children's Central Hospital
name: Maternal and Children's Healthcare Hospital of Taian
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Quanzhou Children's Hospital
name: Chongqing West Hospital
name: Chongqing Medical Center for Women and Children
name: Xiamen Maternity & Child Care Hospital
name: Qujing Maternal and Child Health Hospital
name: Liuzhou Maternity and Child Healthcare Hospital
name: International Peace Maternity and Child Health Hospital
First posted: 2021-12-02
Enrollment: 360
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation
timeFrame: within 72 hrs from the beginning of the study mode
Secondary outcomes:
measure: Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
Other outcomes:
measure: Rate of Bronchopulmonary Dysplasia
timeFrame: 36 weeks of postmenstrual age
measure: Rate of Retinopathy of Prematurity (ROP)≥ 2nd Stage
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Rate of Necrotizing Enterocolitis (NEC) ≥ 2nd Stage
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Rate of Intraventricular Hemorrhage ≥ 3nd Grade
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Rate of Thick Secretions Causing an Airway Obstruction
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: In-hospital Mortality
timeFrame: through study completion, an average of 1 year
measure: Rate of Nasal Trauma
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Composite Mortality/BPD Tality/BPD
timeFrame: through study completion, an average of 1 year
measure: Weekly Weight Gain
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Overall Duration of Non Invasive Respiratory Assistance
timeFrame: the first 4weeks of life or until NICU discharge, whichever comes first
measure: Overall Duration of Hospitalisation
timeFrame: up to 2 years from birth
measure: the Rate of Patent Doctus Arterious
timeFrame: through study completion, an average of 1 year
Locations:
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Qujing
country: China
facility: Qujing Maternity and cChild Healthcare Hospital
state: Yunnan
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Yuan Shi, PhD
role: STUDY_CHAIR
References: