Calfactant + Budesonide for Respiratory Distress Syndrome

Recruiting at1 trial location

Overseen by Dinushan Kaluarachchi, MBBS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age. The main questions it aims to answer are: * Do the combined drugs improve the respiratory severity score (RSS) * Is the combination safe Participants will receive three doses of the study drug.

Research Team

Dinushan Kaluarachchi, MBBS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

The Little Lungs Study is for extremely preterm infants who need mechanical ventilation at 7-14 days old. It's not specified, but typically participants must meet certain health criteria and not have conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

My baby was born between 22 and 28 weeks of pregnancy.

My baby is between 7 to 14 days old.

My baby has a parent or guardian who can consent in English or Spanish.

Exclusion Criteria

Neonate: Not expected to survive for greater than 7 days at enrollment

Neonate: Major congenital anomalies

My newborn has had a lung bleed.

Treatment Details

Interventions

• Budesonide (Corticosteroid)

Trial Overview This trial tests if giving a combination of two drugs, Calfactant and Budesonide, can improve breathing in these infants. They'll get three doses to see if it helps their respiratory severity score without causing harm.

Participant Groups

Group I: Premature babies Experimental Treatment 2 Interventions

Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+