NCT Number: NCT07176117
The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.
Interested in participating?
Request Info33 week–38 week
All sexes
Interventional
Not applicable
Sharp Chula Vista Medical Center, Chula Vista, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Length of hospital stay (LOS), days.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Time to parent bonding from initial parent skin-to-skin contact.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Total duration of mechanical ventilation (MV) with endotracheal tube, days.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Total duration of Continuous Positive Airway Pressure (CPAP), days.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Duration of non-invasive respiratory support with positive pressure and/or high flow, days.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Oxygen administration requirements for Fraction of Inspired Oxygen (FiO2).
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Respiratory Severity Score (RSS)
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Surfactant administration (additional dose administered to infants randomized to receive surfactant or any surfactant to infants receiving expectant CPAP management).
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Time to initial breastfeeding (including dry or nutritive) or oral feeding.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Time to full feeds i.e. no parenteral nutrition.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Incidence of pneumothorax/ pulmonary air leaks.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Defined as any of the following: Respiratory Severity Score (RSS) >2.1, Silverman Andersen (SAS) ≥6, Respiratory acidosis, severe apnea
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Incidence of late onset sepsis.
Time frame: From hospital admission to study completion at hospital discharge after birth.
Maternal total length of stay.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Breastfeeding at time of discharge (yes/no).
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Time to parental skin-to-skin contact
Sharp HealthCare
Other
Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes
Acronym: SPLASH
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