Recruiting

Surfactant Therapy

Sponsor:

Connecticut Children's Medical Center

Code:

NCT06446453

Conditions

Respiratory Distress Syndrome, Newborn

Pulmonary Surfactants

Intensive Care Units, Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Echography-guided Surfactant THERapy (ESTHER)

Study Details

Brief 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.

Conditions

Respiratory Distress Syndrome, Newborn

Pulmonary Surfactants

Intensive Care Units, Neonatal

Study ID

NCT06446453

Start date

Jun 25, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Echography-guided Surfactant THERapy (ESTHER)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jacob Kelner

860-545-9720jkelner@connecticutchildrens.org

Locations

Connecticut Children's

Recruiting

Hartford, Connecticut, United States, 06106

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-07-01.