An interventional study of Echography-guided Surfactant THERapy (ESTHER) in Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants and Intensive Care Units, Neonatal, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged 0 Hours to 2 Hours. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Connecticut Children's Medical Center · Not applicable, Interventional, and Treatment
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.
123 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 24 are open to participants now.
This study's planned enrollment of 52 is below the median of 90 across 93 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.
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).
Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)
Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.
Oxygen Saturation Index
(CPAP Level x FiO2)/(SpO2)
Time frame: At 24 hours of life.
Oxygen Saturation Index
(CPAP Level x FiO2)/(SpO2)
Time frame: At 48 and 72 hours of life.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for May 2027, 35 months after the start.
Of 35 non-industry interventional studies with no phase under Respiratory Distress Syndrome, Newborn, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's planned 35 months is above that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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Respiratory Distress Syndrome, Newborn →
Connecticut Children's Medical Center