Invasive Mechanical VentilationPhase 1/2NCT06855043
Little Lungs Study
A Phase 1/2 study testing Calfactant and Budesonide in people with Invasive Mechanical Ventilation and Severe Respiratory Distress Syndrome, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 14 days
- Conditions the study is for
- Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
- What is being tested?
- Calfactant and Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 days
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Meg Baker contact
United States2 sites
Meriter Hospital
Madison, Wisconsin, 53715
Dinushan Kaluarachchi, (608) 417-6849, kaluarachchi@pediatrics.wisc.edu
American Family Children's Hospital
Madison, Wisconsin, 53792
Dinushan Kaluarachchi, MBBS, (608) 417-6849, kaluarachchi@pediatrics.wisc.edu
About this study
Official title: 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.
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
- Being tested
- Calfactant, Budesonide
- Keywords
- premature birth
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalfactantDrug
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
BudesonideDrug
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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)
Measured: up to 36 0/7 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study startOct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Dinushan Kaluarachchi, MBBS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855043
- Sponsor's protocol ID
- 2024-1479
- Other IDs
- A536757, SMPH\PEDIATRICS\NEONATO, Protocol Version 10/09/25
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT06855043
- Acronym / sponsor ID
- 2024-1479
- Keywords
- premature birth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Premature babies: Study Intervention | Experimental | Drug: Calfactant, Drug: BudesonidePreterm 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) |
| 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) |
Who may qualify
- Ages
- 7 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalfactantParticipants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration | Drug | Premature babies: Study Intervention |
| BudesonideParticipants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration. | Drug | Premature babies: Study Intervention |
Primary outcome
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention
Time frame: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
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.
Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention
Time frame: up to 60 minutes after study intervention (intervention received within 14 DOL)
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.
Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention
Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
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
Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention
Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
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.
3 secondary outcomes
Change in Respiratory Severity Score (RSS)
Time frame: 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)
Time frame: up to 36 0/7 weeks PMA
Days of mechanical ventilation by 36 0/7 weeks PMA
Time frame: up to 36 0/7 weeks PMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meg Baker contact
Dinushan Kaluarachchi, MBBS principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Calfactant and Budesonide in people with Invasive Mechanical Ventilation and Severe Respiratory Distress Syndrome, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dinushan Kaluarachchi, MBBS ((608) 417-6849, kaluarachchi@pediatrics.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention (time frame: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.