Little Lungs Study

Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Invasive Mechanical Ventilation; Severe Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Calfactant; Drug: Budesonide

Detailed Description

Primary Objective

• To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants.

Secondary Objectives

• To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention
• To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Meg Baker; Email: meg.baker@wisc.edu
• Study Contact Backup: Name: Dinushan Kaluarachchi, MBBS; Phone Number: (608) 417-6849; Email: kaluarachchi@pediatrics.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • American Family Children's Hospital
      • Contact: Dinushan Kaluarachchi, MBBS; Phone Number: 608-417-6849; Email: kaluarachchi@pediatrics.wisc.edu
    • Madison, Wisconsin, United States, 53715
      • Meriter Hospital
      • Contact: Dinushan Kaluarachchi; Phone Number: 608-417-6849; Email: kaluarachchi@pediatrics.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Neonate Inclusion Criteria:

• Gestational age 22 0/7 to 28 6/7 weeks at birth
• Age 7-14 days
• Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3

Birthing Parent Inclusion Criteria:

• Have a baby who meets neonate eligibility criteria and enrolls in the study.

Neonate Exclusion Criteria:

• Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and/or genetic disorders
• Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.)
• History of pulmonary hemorrhage
• Antibiotic use within 48 hours
• Indomethacin or Ibuprofen use within 72 hours
• Prior treatment with corticosteroids for prevention of lung disease
• Not expected to survive for greater than 7 days at enrollment
• Determined to be unstable by the clinical team
• Enrolled in a conflicting clinical trial
• Have a birth parent aged less than 18 years
• Parent/guardian is unable to provide parental permission in English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premature babies: Study Intervention; Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 7 days post-intervention)	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.
No Intervention: Premature babies: Standard of Care; Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 10 days post-randomization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention	Presence or absence of acute clinical deterioration - defined as desaturation less than 80 percent and/or bradycardia less than 100 beats per minute (bpm) - during the study intervention and up to 60 minutes after study intervention.	up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention	Presence or absence of severe acute clinical deterioration - defined as desaturation less than 60 percent and/or bradycardia less than 80 bpm - during the study intervention and up to 60 minutes after study intervention.	up to 60 minutes after study intervention (intervention received within 14 DOL)
Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention	A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation from baseline to 48 hours after completion of study intervention	baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention	A yes or no question of whether pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube from baseline to 48 hours after completion of study intervention.	baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Respiratory Severity Score (RSS)	RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms.	Baseline to 7 days post-intervention (intervention received within 14 DOL)
Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA)		up to 36 0/7 weeks PMA
Days of mechanical ventilation by 36 0/7 weeks PMA	Days of mechanical ventilation by 36 0/7 weeks PMA (If an infant died before 36 0/7 weeks, time from death to 36 0/7 weeks PMA will be considered as mechanical ventilation days)	up to 36 0/7 weeks PMA

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Meriter Foundation
• Investigators: Principal Investigator: Dinushan Kaluarachchi, MBBS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: premature birth
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Premature Birth; Respiratory Distress Syndrome; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide; calfactant
• Other Study ID Numbers: 2024-1479; A536757 (Other Identifier: UW- Madison); SMPH\PEDIATRICS\NEONATO (Other Identifier: UW Madison); Protocol Version 10/09/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No