Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure

Connecticut Children's Medical Center

Status: Enrolling

Conditions: Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Intensive Care Units, Neonatal

Treatments: Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)

Study type: Interventional

Funder types: Other

Identifiers

NCT06446453

24-005-CCMC

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: Under 2 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.

Treatment

Experimental group

Description:

The treatment group will receive surfactant therapy if the initial LUS at 1-2 hours of life is \> 9 or if they meet our unit's current surfactant therapy guidelines (irrespective of the LUS).

Treatment:

Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)