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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446453
• Other study ID #: 24-005-CCMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Connecticut Children's Medical Center
• Contact: Jacob Kelner
• Phone: 860-545-9720
• Email: jkelner[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 2 Hours

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Units, Neonatal
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Echography-guided Surfactant THERapy (ESTHER)
Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Saturation Index	(CPAP Level x FiO2)/(SpO2)	At 24 hours of life.
Secondary	Oxygen Saturation Index	(CPAP Level x FiO2)/(SpO2)	At 48 and 72 hours of life.