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Little Lungs Study

NCT06855043 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-27

No results posted yet for this study

Summary

This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

Conditions

  • Invasive Mechanical Ventilation
  • Severe Respiratory Distress Syndrome

Interventions

DRUG

Calfactant

Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration

DRUG

Budesonide

Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.

Sponsors & Collaborators

  • Meriter Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Dinushan Kaluarachchi, MBBS · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855043 on ClinicalTrials.gov