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Not yet recruitingNCT06855043Updated Sep 29, 2026

Little Lungs Study

A Phase 1/2 interventional study of Calfactant and Budesonide in Invasive Mechanical Ventilation and Severe Respiratory Distress Syndrome, sponsored by University of Wisconsin, Madison. Not yet recruiting at 2 sites in United States. Open to participants aged 7 Days to 14 Days. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University of Wisconsin, Madison · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
7 Days to 14 Days
Sex
All
01

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.

Read the 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
02

Conditions studied

  • Invasive Mechanical Ventilation
  • Severe Respiratory Distress Syndrome

Keywords

  • premature birth
03

Who can participate

Ages eligible
7 Days to 14 Days
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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 · Drug: Budesonide

  • 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)

Interventions

  • DrugCalfactant

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

  • DrugBudesonide

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))

  2. 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.

    Time frame: up to 60 minutes after study intervention (intervention received within 14 DOL)

  3. 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

    Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)

  4. 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.

    Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)

Secondary outcomes

  1. 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.

    Time frame: Baseline to 7 days post-intervention (intervention received within 14 DOL)

  2. Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA)

    Time frame: up to 36 0/7 weeks PMA

  3. 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)

    Time frame: up to 36 0/7 weeks PMA

06

Study locations

2 sites
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06855043
Lead sponsor
University of Wisconsin, Madison
Collaborators
Meriter Foundation
Responsible party
Sponsor
First posted
Mar 3, 2025
Start date
Oct 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Dinushan Kaluarachchi, MBBS
Contact
kaluarachchi@pediatrics.wisc.edu
(608) 417-6849
Meg Baker
Contact
meg.baker@wisc.edu
Dinushan Kaluarachchi, MBBS
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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