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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorConnecticut Children's Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Echography-guided Surfactant THERapy (ESTHER)

    Diagnostic test

    Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen Saturation Index

(CPAP Level x FiO2)/(SpO2)

Time frame
At 24 hours of life.

Secondary outcomes

1

Oxygen Saturation Index

(CPAP Level x FiO2)/(SpO2)

Time frame
At 48 and 72 hours of life.

Other outcomes

Sponsors and contacts

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