NHFOV as Primary Support in Very Preterm Infants With RDS
- Conditions
- to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
- Interventions
- Procedure: infants receive primary non-invasive respiratory support by mean of nCPAPProcedure: infants receive primary non-invasive respiratory support by mean of NHFOV
- Registration Number
- NCT05141435
- Lead Sponsor
- Jiulongpo No.1 People's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
(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
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Intubated forany reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NCPAP infants receive primary non-invasive respiratory support by mean of nCPAP - NHFOV infants receive primary non-invasive respiratory support by mean of NHFOV - NCPAP infants receive primary non-invasive respiratory support by mean of NHFOV - NHFOV infants receive primary non-invasive respiratory support by mean of nCPAP -
- Primary Outcome Measures
Name Time Method Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation within 72 hrs from the beginning of the study mode The respiratory support failure will be considered if one of the following occurs: (1) severe respiratory acidosis (defined as PaCO2 \>60mm Hg with pH\<7.2) for at least 1hour; (2) hypoxia refractory to study intervention (defined as SpO2 \<90%, with FiO2=0.4 and maximal pressures allowed in the study arm) for at least 1 hour after the administration of surfactant; (3) severe apnoea (defined as recurrent apnoea with \>3 episodes/hour associated with heart rate \<100/min or a single episode of apnoea requiring bag and mask ventilation) and (4) attending physician determined that urgent intubation is necessary.
- Secondary Outcome Measures
Name Time Method Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support the first 4weeks of life or until NICU discharge, whichever comes first the diagnosis a Chest XR
Trial Locations
- Locations (3)
Hunan Provincial Maternal and Child Health Care Hospital
🇨🇳Changsha, Hunan, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Qujing Maternity and cChild Healthcare Hospital
🇨🇳Qujing, Yunnan, China