To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation

N/AEnrolling By InvitationNCT07235345

Xu Falin500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the thresholdOTHER

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.

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Duration of tracheal intubation and mechanical ventilation

The duration of invasive mechanical ventilation was observed

Time frame: The children required tracheal intubation and mechanical ventilation during hospitalization, and the observation time was about 2 months

Time of first PS use

The time from the first use of PS to birth was observed

Time frame: Time to first use of pulmonary surfactant within 6 hours after birth

Duration of noninvasive assisted ventilation

The duration of noninvasive mechanical ventilation was observed during hospitalization

Time frame: Noninvasive ventilation was required during hospitalization, and the observation time was about 2 months

Repeat PS usage rate

Whether PS was used repeatedly during hospitalization was observed

Time frame: The frequency of repeated use of pulmonary surfactant during hospitalization was observed for about 1 week after birth

Days of Oxygen therapy

The time of oxygen therapy during hospitalization was observed

Time frame: The children needed oxygen inhalation for a number of days during hospitalization, and the observation time was about 2 months

Failure rate of noninvasive treatment

The use of invasive mechanical ventilation after birth was observed

Time frame: 72 hours after birth