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

Not Applicable

Recruiting

• Conditions: Respiratory Distress Syndrome, Newborn; Intensive Care Units, Neonatal; Pulmonary Surfactants
• Interventions: Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)

• Registration Number: NCT06446453
• Lead Sponsor: Connecticut Children's Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Study Start: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Echography-guided Surfactant THERapy (ESTHER)	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).

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation Index	At 24 hours of life.	(CPAP Level x FiO2)/(SpO2)

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation Index	At 48 and 72 hours of life.	(CPAP Level x FiO2)/(SpO2)

Trial Locations

Locations (1)

Connecticut Children's; 🇺🇸 Hartford, Connecticut, United States