Jiulongpo No.1 People's Hospital
xingwangzhu
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.
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
infants receive primary non-invasive respiratory support by mean of nCPAP
infants receive primary non-invasive respiratory support by mean of NHFOV
Not Applicable
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 340 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | NHFOV vs nCPAP in Very Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial |
Actual Study Start Date : | August 1, 2022 |
Estimated Primary Completion Date : | February 15, 2023 |
Estimated Study Completion Date : | April 15, 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: NCPAP |
Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV |
Active Comparator: NHFOV |
Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV |
Ages Eligible for Study: | 0 Hours to 2 Hours |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China,
Recruiting
The Second Hospital of Shandong University
women, Shandong, China,
Recruiting
Qujing Maternity and child Healthcare Hospital
Q u fine, Yunnan, China,