Little Lungs Study

Conditions

• Invasive Mechanical Ventilation
• Severe Respiratory Distress Syndrome

Eligibility Criteria

Sex

ALL

Age

7 Days - 14 Days

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 30, 2026

Status verified

Jan 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Premature babies: Study Intervention
  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)
• No Intervention: Premature babies: Standard of Care
  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)

Primary Outcome Measure

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)) ]

Central Contacts

• Dinushan Kaluarachchi, MBBS
  (608) 417-6849
  [email protected]
• Meg Baker
  [email protected]

Locations (2)

Find similar trials in Madison, WI

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