Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Conditions
Keywords
premature birth
Brief 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
Interventions
DRUGCalfactant
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
DRUGBudesonide
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
Sponsors
University of Wisconsin, Madison
Meriter Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a phase I/II pilot randomized controlled clinical trial to obtain preliminary data on safety and clinical response of multiple doses of late surfactant treatment with budesonide
Eligibility
Sex/Gender
ALL
Age
7 Days to 14 Days
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of acute clinical deterioration up to 60 minutes after study intervention | up to 60 minutes after study intervention (intervention received within 14 days of life (DOL)) | 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. |
| Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention | up to 60 minutes after study intervention (intervention received within 14 DOL) | 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. |
| Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention | baseline to 48 hours after completion of study intervention (intervention received within 14 DOL) | 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 |
| Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention | baseline to 48 hours after completion of study intervention (intervention received within 14 DOL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Respiratory Severity Score (RSS) | Baseline to 7 days post-intervention (intervention received within 14 DOL) | RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms. |
| Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA) | up to 36 0/7 weeks PMA | — |
| Days of mechanical ventilation by 36 0/7 weeks PMA | up to 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) |
Countries
United States
Contacts
CONTACTDinushan Kaluarachchi, MBBS
CONTACTMeg Baker
PRINCIPAL_INVESTIGATORDinushan Kaluarachchi, MBBS
University of Wisconsin, Madison
Outcome results
None listed