Little Lungs Study

Phase 2

Not yet recruiting

• Conditions: Invasive Mechanical Ventilation; Severe Respiratory Distress Syndrome
• Interventions: Drug: Calfactant; Drug: Budesonide

• Registration Number: NCT06855043
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

The main questions it aims to answer are:

* Do the combined drugs improve the respiratory severity score (RSS)

* Is the combination safe

Participants will receive three doses of the study drug.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-06-30
• Study Start: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Gestational age 22 0/7 to 28 6/7 weeks at birth
• Age 7-14 days
• Need invasive mechanical ventilatory support
• Have at least one parent/guardian who is able to provide parental permission in English or Spanish

Birthing Parent Inclusion Criteria:

• Have a baby who meets neonate eligibility criteria and enrolls in the study.
• Is able to provide consent in English or Spanish

Neonate

Exclusion Criteria

• Major congenital anomalies
• History of pulmonary hemorrhage
• Antibiotic use within 48 hours
• Prior treatment with corticosteroids for prevention of lung disease
• Indomethacin or Ibuprofen use within 72 hours
• Have a birth parent aged less than 18 years
• Respiratory severity score less than 2.4
• Not expected to survive for greater than 7 days at enrollment

Birthing Parent Exclusion Criteria:

• Is aged less than 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Premature babies	Calfactant	Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life
Premature babies	Budesonide	Preterm infants born at gestational age less than 29 0/7 weeks requiring mechanical ventilation at 7-14 days of life

Primary Outcome Measures

Name	Time	Method
Change in respiratory severity score (RSS)	Baseline to 48 hours	RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in RSS	Baseline to 7 days	RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms.
Presence or absence of acute clinical deterioration	Up to 3 days	Oxygen saturation less than 80 percent and/or heart rate less than 100 beats per minute (bpm).
Presence or absence of severe acute clinical deterioration	Up to 3 days	Oxygen saturation less than 60 percent and/or heart rate less than 80 bpm.
Change in average daily apnea bradycardia desaturation (ABD) events	Baseline to 5 days	ABD events are defined as (1) Apnea greater than 20 seconds, or (2) Apnea less than 20s that is associated with heart rate less than 100bpm and/or oxygen saturation less than 80 percent.
Occurrence of pneumothorax	Up to 5 days	A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation.
Occurrence of pulmonary hemorrhages	Up to 5 days	A yes or no question of whether there was pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube.
Compare observed Bronchopulmonary Dysplasia (BPD) grades with estimated BPD grade	up to 36 weeks post menstrual age	To see if there has been a change in the observed BPD grade after completion of the study intervention compared to the estimated BPD grade prior to study enrollment, the ratio of estimated BPD grades based on 2022 Neonatal Research Network (NRN) BPD estimator to observed BPD grades at 36 0/7 weeks will be reported.

Trial Locations

Locations (2)

Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States