Little Lungs Study

NCT06855043 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 2024-1479A536757SMPH\PEDIATRICS\NEONATOProtocol Version 10/09/25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Severe Respiratory Distress Syndrome; Invasive Mechanical Ventilation

Keywords

premature birth

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in Respiratory Severity Score (RSS)

  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

  up to 36 0/7 weeks PMA

Study Arms (2)

Premature babies: Study Intervention

EXPERIMENTAL

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; Drug: Budesonide

Premature babies: Standard of Care

NO 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 10 days post-randomization)

Interventions

Calfactant DRUG

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

Premature babies: Study Intervention

Budesonide DRUG

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

Premature babies: Study Intervention

Eligibility Criteria

• Age: 7 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Foundation: collaborator

Study Sites (2)

Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Interventions

calfactant; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dinushan Kaluarachchi, MBBS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinushan Kaluarachchi, MBBS

CONTACT

(608) 417-6849; kaluarachchi@pediatrics.wisc.edu

Meg Baker

CONTACT

meg.baker@wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase I/II pilot randomized controlled clinical trial to obtain preliminary data on safety and clinical response of multiple doses of late surfactant treatment with budesonide

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (2)