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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT06446453
Status
Recruiting
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Conditions

  • Intensive Care Units, Neonatal
  • Pulmonary Surfactants
  • Respiratory Distress Syndrome, Newborn

Eligibility Criteria

Sex
ALL
Age
0 Hours - 2 Hours
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 25, 2024
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    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.
  • Experimental: Treatment
    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).

Primary Outcome Measure

Oxygen Saturation Index [ Time Frame: At 24 hours of life. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children'sHartfordConnecticut06106
Little

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By research site
Connecticut Children's· Hartford, CT

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