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NCT Number: NCT06446453

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

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.

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Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Intensive Care Units, Neonatal Lung Diseases Pulmonary Surfactants Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

0 hour–2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Little

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echography-guided Surfactant THERapy (ESTHER)

Diagnostic Test

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

Primary outcomes

  1. Oxygen Saturation Index

    Time frame: At 24 hours of life.

    (CPAP Level x FiO2)/(SpO2)

Secondary outcomes

  1. Oxygen Saturation Index

    Time frame: At 48 and 72 hours of life.

    (CPAP Level x FiO2)/(SpO2)

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Kelner

CONTACT

[email protected]

860-545-9720

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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