Respiratory Distress Syndrome (Neonatal), Surfactant
Conditions
Keywords
preterm infants, surfactant therapy, respiratory distress syndrome
Brief summary
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 above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems 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?
Interventions
PROCEDURESurfactant Administration through Laryngeal or Supraglottic Airway
Surfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL
PROCEDURESurfactant Administration through Thin Catheter
Thin Catheter
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* All preterm infants born between 29-36 weeks' gestation. * Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure
Exclusion criteria
* Infants who require intubation prior to surfactant therapy * Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies) * Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration | Time of laryngoscope or supraglottic airway device insertion to removal of device | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate on first attempt | At time of surfactant administration procedure | * Procedure attempt is defined at the introduction of laryngoscope blade into mouth for LISA, supraglottic airway for SALSA. * Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant with less than 25% of surfactant aspirated from the stomach post administration * Rate will be calculated as a percentage of participants in each arm |
| Intubation rate | From time of procedure to 72 hours of life | * 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 |
| Mean number of attempts required | At time of surfactant administration | Procedure attempt will be defined as introduction of laryngoscope blade into mouth for LISA and introduction of supraglottic airway into mouth for SALSA. |
| Total duration of CPAP and mechanical ventilation days | Up to 52 weeks | Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation |
Countries
United States
Contacts
CONTACTMelody Chiu, M.D.
CONTACTKathryn Mazioniene, R.N.
PRINCIPAL_INVESTIGATORMelody Chiu, M.D.
University of Texas Southwestern Medical Center
Outcome results
None listed