Calfactant + Budesonide for Respiratory Distress Syndrome

Recruiting at 1 trial location

Overseen By Meg Baker

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Antibiotics, Corticosteroids, Indomethacin, Ibuprofen

Disqualifiers: Congenital anomalies, Pulmonary hemorrhage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if participants must stop taking their current medications, but it does exclude neonates who have used antibiotics within 48 hours or Indomethacin or Ibuprofen within 72 hours.

What data supports the effectiveness of the drug Budesonide combined with Calfactant for treating Respiratory Distress Syndrome?

Research shows that combining budesonide with a surfactant improves oxygen levels and reduces lung injury in animal models of respiratory distress syndrome. Additionally, this combination may help prevent bronchopulmonary dysplasia (a chronic lung disease) in premature infants. ^{1 2 3 4 5}

Is the combination of calfactant and budesonide safe for treating respiratory distress syndrome?

Research suggests that combining budesonide with surfactants like calfactant is generally safe for treating respiratory distress syndrome in premature infants. Studies have shown that this combination does not negatively affect the treatment's effectiveness and may reduce lung inflammation. ^{1 3 4 6 7}

How is the drug Calfactant + Budesonide unique for treating respiratory distress syndrome?

The combination of Calfactant, a natural bovine surfactant, and Budesonide, a corticosteroid, is unique because it combines surfactant therapy with anti-inflammatory effects, potentially enhancing treatment efficacy for respiratory distress syndrome in premature infants compared to using surfactant alone. ^{1 7 8 9 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive three doses of the study drug, budesonide, for late surfactant therapy

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in respiratory severity score and other clinical outcomes

7 days

Long-term follow-up

Participants are monitored for long-term outcomes such as Bronchopulmonary Dysplasia (BPD) grades

up to 36 weeks post menstrual age

Treatment Details

Interventions

• Budesonide

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+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

References

1. China pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of different pulmonary surfactants in premature infants with respiratory distress syndrome]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intratracheal budesonide supplementation in addition to surfactant improves pulmonary outcome in surfactant-depleted newborn piglets. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Dose of budesonide with surfactant affects lung and systemic inflammation after normal and injurious ventilation in preterm lambs. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of early combined utilization of budesonide and surfactant by airway for bronchopulmonary dysplasia prevention in premature infants with RDS: A meta-analysis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy of different preparations of budesonide combined with pulmonary surfactant in the treatment of neonatal respiratory distress syndrome: a comparative analysis]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterization of poractant alfa supplemented with budesonide for safe and effective intratracheal administration. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Calfactant: a review of its use in neonatal respiratory distress syndrome. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

An open label comparison of calfactant and poractant alfa administration traits and impact on neonatal intensive care unit resources. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Calfactant sterility in multiple doses from single-use vials. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial. [2023]