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Not yet recruiting NCT06855043

Little Lungs Study

Phase I / Phase II Interventional Invasive Mechanical Ventilation Severe Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calfactant, Budesonide.
Who it may be relevant to
Registry conditions: Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome. Basic parameters: 7 Days — 14 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Calfactant
    Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
  • Drug Budesonide
    Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.

Primary outcome measures

  • 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 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)]
  • 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)]
  • 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)]
Secondary outcome measures (3)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Meriter Hospital — Madison
  • American Family Children's Hospital — Madison

Identifiers

NCT: NCT06855043 · 2024-1479 · A536757 · SMPH\PEDIATRICS\NEONATO · Protocol Version 10/09/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗