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Little Lungs Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

Little Lungs Study

Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia

NCT06855043•University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

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

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

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
+1 more criteria

Locations (2)

Meriter Hospital

Madison, Wisconsin, United States

American Family Children's Hospital

Madison, Wisconsin, United States

Key Dates

Start Date

September 1, 2026

Primary Completion Date

March 1, 2029

Completion Date

March 1, 2029

Last Updated

January 27, 2026

Enrollment

ESTIMATED participants

Conditions

Invasive Mechanical VentilationSevere Respiratory Distress Syndrome

Interventions

Calfactant

DRUG

Budesonide

DRUG

Contacts

Dinushan Kaluarachchi, MBBS

CONTACT

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

Meg Baker

CONTACT

meg.baker@wisc.edu

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

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RECRUITINGNA

Endotracheal Suctionning During Positive Pressure Extubation in ICU

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Little Lungs Study

Inclusion Criteria

Exclusion Criteria

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

Endotracheal Suctionning During Positive Pressure Extubation in ICU

Evaluation of Rehabilitation Practices in the Intensive Care Unit

Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation

Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation

Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)