What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for infants who are born at or after 29 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer breathing-related problems and fewer short-term complications than those who receive it using the LISA method. What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Surfactant Administration through Supraglottic Airway Devices * Air-Q3 size 0 for neonates: \< 2 kilograms * i-gel supraglottic airway size 1 for neonates: ≥ 2 kilograms
Thin Catheter
Number of events of bradycardia and hypoxemia during surfactant administration
* Bradycardia: defined as heart rate \< 100 beats per minute for \> 10 seconds. Heart rate will be obtained from participant's heart rate monitor. * Hypoxemia: oxygen saturation (SpO2) =\< 80% for \> 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor * Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure
Time frame: Time of surfactant administration to completion of procedure
Procedural success rate on first attempt
* Procedure attempt is defined at the introduction of laryngoscope blade into mouth. * Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant without surfactant aspirated from the stomach post administration * Rate will be calculated as a percentage of participants in each arm
Time frame: At time of surfactant administration procedure
Intubation rate
* Rate will be calculated as a percentage of participants in each arm Invasive mechanical ventilation within first 72 hours of life after surfactant * Participants' need for and timing of intubation will be obtained from electronic medical record
Time frame: From time of procedure to 72 hours of life
Mean number of attempts required
Procedure attempt will be defined as introduction of laryngoscope blade into mouth.
Time frame: At time of surfactant administration
Total duration of CPAP and mechanical ventilation days
Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation
Time frame: Up to 52 weeks
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