RecruitingNot ApplicableNCT06446453

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


Sponsor

Connecticut Children's Medical Center

Enrollment

52 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 HoursMax Age: 2 Hours

Inclusion Criteria3

  • 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 Criteria6

  • 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

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Interventions

DIAGNOSTIC_TESTEchography-guided Surfactant THERapy (ESTHER)

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


Locations(1)

Connecticut Children's

Hartford, Connecticut, United States

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NCT06446453


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