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 2026-11-02.
Sponsored by University of Wisconsin, Madison · Phase 1/2, Interventional, and Treatment
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Among 324 studies in Respiratory Distress Syndrome with a site in United States — 46 open to participants now, 56 under way, 7 of them phase 3. Respiratory Distress Syndrome · United States.
Among the 324 studies in Respiratory Distress Syndrome with a site in United States, this one is the 165th largest by planned enrollment of the 250 interventional ones that give a count, is the only one that started in 2027, is one of 17 in phase 1/2, reaches primary completion later than 48 of the 55 other live ones, and was the 307th registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.
Browse Respiratory Distress Syndrome studies →46 of the 324 studies in Respiratory Distress Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 7 days–30 days
Ohio State University · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 0 hrs–72 hrs
Massachusetts General Hospital · Sites in United States
Ages 18–80
Implicit Bioscience · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 193 Respiratory Distress Syndrome studies recruiting now, 117 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 50 take children under 18; 9 take healthy volunteers.
This study: 7 Days to 14 Days · all sexes · no healthy volunteers.
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324 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 101 · Phase 3 46 · Phase 4 6
First in 1991; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Median enrollment 52 across the 250 interventional studies, 85 across the 68 observational. Of the 220 that completed or were terminated, 101 (46%) have results posted.
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75 of 324 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 3 studies filed under Respiratory Distress Syndrome — fewer than ten, so there is no comparison to draw.
20 of the studies in Respiratory Distress Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06776783Phase 3Aerogen Pharma LimitedSafety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome | 2027-05 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT05354141Phase 3Direct Biologics, LLCExtracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) | 2027-11-30 |
| NCT04369599Emory UniversityTrans Thoracic Manipulation of Ventilation/Perfusion: the V/Q System | 2026-11 |
| NCT07674953University of ArkansasHow Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants | 2026-12 |
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Among the 324 studies in Respiratory Distress Syndrome with a site in United States, from their registry updates:
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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.
Primary Objective
Secondary Objectives
Neonate Inclusion Criteria:
Birthing Parent Inclusion Criteria:
Neonate Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
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))
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)
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)
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)
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)
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
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
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Aug 2029, 30 months later.
Of 25 phase 1/2 interventional studies under Respiratory Distress Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 30 months is above that.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Feb 2027, last on Nov 2, 2026.
Primary completion moved once since we started tracking on Sep 25, 2026: Mar 2029 → Aug 2029, on Nov 2, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Mar 2029 → Aug 2029, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Budesonide
Respiratory Distress Syndrome →
University of Wisconsin, Madison →