InfasurfAero™ for Respiratory Distress Syndrome in Preterm Newborns
This study is testing a new way to give Infasurf®, a medicine for Respiratory Distress Syndrome (RDS) in preterm babies. RDS is a breathing problem common in babies born early. Instead of using a breathing tube, Infasurf® is given through a special device called InfasurfAero™ with a pacifier. This study wants to see if giving Infasurf® this way helps prevent babies from needing more breathing support or dying within their first week of life. We are looking for babies born between 29 and 36 weeks gestation, weighing between 1,000 and 3,500 grams, and who are 1 to 6 hours old with RDS. The study plans to enroll 220 babies, and 7 out of 10+ sites are currently enrolling participants.
- Study design
- This is a double-blind, randomized study where babies will either receive Infasurf® or air alone through the InfasurfAero™ device. About 220 babies will participate.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study is measured within the baby's first week of age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
At a glance
Conditions
NCT05960929
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Jersey Shore University Medical Center
Neptune City, New Jerseystudy coordinator listed
Recruiting
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaiistudy coordinator listed
Recruiting
Phoenix Children's
Phoenix, Arizonastudy coordinator listed
Recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, Californiastudy coordinator listed
Recruiting
Sisters of Charity Hospital
Buffalo, New Yorkstudy coordinator listed
Recruiting
St. Josephs Hospital and Medical Center
Phoenix, Arizonastudy coordinator listed
Recruiting
Unity Point Meriter
Madison, Wisconsinstudy coordinator listed
Recruiting
University of Florida -Jacksonville
Jacksonville, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Scott Guthrie, MD · STUDY_CHAIR · Vanderbilt Jackson-Madison, Jackson TN
- Dinushan Kaluarachchi, MD · STUDY_CHAIR · Unity Point Meriter, Madison WI
- Jim Cummings, MD · STUDY_DIRECTOR · Ony Biotech
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- CPAP failure and or deathWithin 1st week of age
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) \>2.5 on two consecutive assessments at least 30 minutes apart, or an RSS \> 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 \> 65 with a pH \< 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.