Neonatal respiratory distress syndrome
Conditions
Interventions
experimental group:PS administration method: New dual lumen tracheal intubation surfactant extubation (InSurE)
control group:Minimally Invasive Surfactant Administration (LISA)
Sponsors
Qujing Maternal and Child Health Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 0.1 Years
Inclusion criteria
Inclusion criteria: Newborns who meet all the following criteria will be considered for inclusion in the study: ? Premature infants with gestational age less than 32 weeks. ? Transfer to our NICU within 6 hours after birth and provide non-invasive respiratory support, with FiO2>30% to maintain saturation between 90% and 95%; ? Diagnosed as NRDS based on clinical manifestations and chest imaging features; ? Obtained written informed consent from parents
Exclusion criteria
Exclusion criteria: If a patient experiences any of the following situations, they will be excluded. ? Severe congenital malformations, known complex congenital heart disease, or congenital lung developmental abnormalities; ? Chromosome abnormalities or hereditary metabolic disorders; ? Neuromuscular diseases that affect respiratory function; ? Level 3 or 4 intraventricular hemorrhage (IVH); ? Mechanical ventilation is required in the delivery room or immediately upon clinical judgment. ? Before enrollment, exogenous surfactants were applied; ? Transferred out of the neonatal intensive care unit before randomization; ? Require surgical treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanical ventilation rate within 72 hours after birth; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mechanical ventilation duration, non-invasive ventilation duration, oxygen therapy duration, and hospitalization duration;The age at which the patient began receiving non-invasive ventilation and the age at which the patient received the first intratracheal surfactant administration, in minutes;The duration of intubation (from inserting the laryngoscope into the mouth to successfully removing the laryngoscope after intubation), the duration of drug injection (from inserting the syringe into the mouth to removing the syringe), and the total operation time (from the beginning of intubation to the end of drug infusion).;The number of intubation attempts before successful administration;Bradycardia (heart rate200 beats/min), low saturation (SpO2 = 80%), and oral mucosal or gingival damage during the administration process.;Surface active agent reflux rate, incidence of uneven surface active agent administration, proportion of repeated surface active agent administration;SpO2, FiO2, pH, PaCO2, PO2 before, during, and after administration of surfactants. For infants who received multiple intratracheal surfactant doses, only the data from the first operation were reported.;he main complications include air leakage, NEC (Bells stage 2 or above), retinopathy of prematurity (defined as 2-4 according to international classification), IVH (Paple classification 3-4), PVL, pulmonary hemorrhage, BPD, and death.; | — |
Countries
China
Contacts
Public ContactChuanfeng Li
Qujing Maternal and Child Health Hospital
Outcome results
None listed