Neonatal Respiratory Distress Syndrome
Conditions
Brief summary
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of \<32 weeks were enrolled. All infants received routine treatment after birth and were randomly divided into two groups according to the FiO2 threshold of PS under noninvasive assisted ventilation: Control group (FiO2=0.30) and low concentration group (FiO2=0.25). Clinical data were collected to explore the differences in clinical outcomes between the two groups.
Detailed description
① All the very/extremely preterm infants who met the criteria were divided into low concentration group and high concentration group according to the random number table method. The pressure, respiratory rate and other parameters were set according to the relevant clinical guidelines or expert consensus. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. To maintain SpO2 90%-94%. According to the FiO2 threshold corresponding to randomization, PS treatment was given when FiO2 reached the threshold (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be repeated if necessary if the disease progressed). PS treatment was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used. ② The basic information and perinatal outcomes of the two groups were collected; Outcome indicators: the main outcome indicators were the failure rate of non-invasive treatment, the time of tracheal intubation mechanical ventilation, the time of non-invasive assisted ventilation, the days of oxygen therapy, the time of the first use of PS, and the rate of repeated PS. The secondary outcomes included mortality, incidence of BPD, incidence of ROP, oxygen demand at 28 days after birth and 36 weeks of corrected gestational age, oxygen demand at discharge, length of hospital stay, and cost of hospitalization.
Interventions
OTHERAccording to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
According to the relevant clinical guidelines or expert consensus, the pressure, respiratory rate and other parameters were set. The initial FiO2 was 21% when PEEP was ≥6 cmH2O. FiO2 was adjusted according to the respiration and percutaneous oxygen saturation (SpO2) of the children. To maintain SpO2 90%-94%. According to the FiO2 threshold corresponding to randomization, PS treatment was given when FiO2 reached the threshold (the initial dose was 200mg/kg, and the second or third dose of 100mg/kg could be repeated if necessary if the disease progressed). PS treatment was administered as early as possible within 6 hours after birth. Endotracheal intubation, INSURE technique, or LISA technique can be used.
Sponsors
Zhumadian Central Hospital
Zhengzhou Central Hospital
Xinyang Central Hospital
Xinxiang Central Hospital
Nanyang Central Hospital
Zhoukou Central Hospital
Xu Falin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Very preterm infants with gestational age \<32 weeks * immediately transferred to the neonatal intensive care unit * signs of respiratory distress or RDS requiring respiratory support; * Informed consent was obtained from the families of the children.
Exclusion criteria
* Giving up treatment or being transferred to other hospitals during hospitalization; * requiring mechanical ventilation with tracheal intubation immediately or within 2 hours after birth * complicated with pneumothorax, complex congenital heart disease, congenital malformation, congenital cystic lung disease, chromosomal inherited metabolic diseases, etc * Incomplete clinical data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of tracheal intubation and mechanical ventilation | The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months | The duration of invasive mechanical ventilation was observed |
| Time of first PS use | Time to first use of pulmonary surfactant within 6 hours after birth | The time from the first use of PS to birth was observed |
| Duration of noninvasive assisted ventilation | Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months | The duration of noninvasive mechanical ventilation was observed during hospitalization |
| Repeat PS usage rate | The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth | Whether PS was used repeatedly during hospitalization was observed |
| Days of Oxygen therapy | The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months | The time of oxygen therapy during hospitalization was observed |
| Failure rate of noninvasive treatment | 72 hours after birth | The use of invasive mechanical ventilation after birth was observed |
Countries
China
Outcome results
None listed