Intensive Care Units, Neonatal, Pulmonary Surfactants, Respiratory Distress Syndrome, Newborn
Conditions
Brief summary
Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.
Interventions
DIAGNOSTIC_TESTEchography-guided Surfactant THERapy (ESTHER)
Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.
Sponsors
Connecticut Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 2 Years
Healthy volunteers
No
Inclusion criteria
* The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study * Birth gestational age between 27w0d-36w6d * Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation
Exclusion criteria
* Unable to obtain lung ultrasound between 1-2 hours of life * Infants already intubated or received surfactant before the point of care lung ultrasound * Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations * Infants born with chromosomal abnormalities * Infants with APGARs ≤ 5 at 10 minutes of life * Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Index | At 24 hours of life. | (CPAP Level x FiO2)/(SpO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Index | At 48 and 72 hours of life. | (CPAP Level x FiO2)/(SpO2) |
Countries
United States
Contacts
CONTACTJacob Kelner
PRINCIPAL_INVESTIGATORJacob Kelner
Connecticut Children's
Outcome results
None listed