Health TrialsbyHealthPanel

Little Lungs Study

ConditionsInvasive Mechanical VentilationSevere Respiratory Distress Syndrome
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age7-14
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Premature babies: Study InterventionExperimental treatment 2 interventions
Group B: Premature babies: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Presence or absence of acute clinical deterioration up to 60 minutes after study intervention

Presence or absence of acute clinical deterioration - defined as desaturation less than 80 percent and/or bradycardia less than 100 beats per minute (bpm) - during the study intervention and up to 60 minutes after study intervention.

Time frame
up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
2

Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention

Presence or absence of severe acute clinical deterioration - defined as desaturation less than 60 percent and/or bradycardia less than 80 bpm - during the study intervention and up to 60 minutes after study intervention.

Time frame
up to 60 minutes after study intervention (intervention received within 14 DOL)
3

Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention

A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation from baseline to 48 hours after completion of study intervention

Time frame
baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
4

Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention

A yes or no question of whether pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube from baseline 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 outcomes

1

Change in Respiratory Severity Score (RSS)

RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms.

Time frame
Baseline to 7 days post-intervention (intervention received within 14 DOL)
2

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
3

Days of mechanical ventilation by 36 0/7 weeks PMA

Days of mechanical ventilation by 36 0/7 weeks PMA (If an infant died before 36 0/7 weeks, time from death to 36 0/7 weeks PMA will be considered as mechanical ventilation days)

Time frame
up to 36 0/7 weeks PMA

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Meriter Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: