Little Lungs Study

University of Wisconsin (UW)

Status and phase: Begins enrollment in 6 months; Phase 2; Phase 1

Conditions: Invasive Mechanical Ventilation; Severe Respiratory Distress Syndrome

Treatments: Drug: Budesonide; Drug: Calfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT06855043

Protocol Version 10/09/25 (Other Identifier)

A536757 (Other Identifier)

2024-1479

SMPH\PEDIATRICS\NEONATO (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 7 to 14 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Premature babies: Study Intervention

Experimental group

Description:

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)

Treatment:

Drug: Budesonide

Drug: Calfactant

Premature babies: Standard of Care

No Intervention group

Description:

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)