Using ultrasound to guide surfactant therapy for preterm infants with breathing difficulties
Official title: Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Run by Connecticut Children's Medical Center · NCT06446453 · Data updated 2026-11-12
This study is testing if using ultrasound to help give surfactant treatment can improve breathing for preterm infants with respiratory problems compared to the usual methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Hours to 2 Hours |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | May 2027 |
| Study ends | June 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06446453 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born between 27 and 36 weeks of gestation who are experiencing respiratory failure due to RDS and require non-invasive ventilation.
✕Probably not a fit
Patients who are already intubated, have received surfactant prior to the ultrasound, or have significant congenital abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of point-of-care ultrasound (POCUS) to assess the severity of respiratory distress syndrome (RDS) in preterm infants and guide surfactant therapy. By employing lung ultrasound scores, the study aims to determine if earlier surfactant administration can improve respiratory outcomes compared to standard treatment protocols. The trial will compare the effectiveness of ultrasound-guided surfactant therapy against current guidelines in a neonatal intensive care setting.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory outcomes for preterm infants suffering from respiratory distress syndrome.
How similar studies have gone: While the use of ultrasound in neonatal care is gaining traction, this specific approach to guiding surfactant therapy is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Connecticut Children's
Hartford, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Jacob Kelner — Connecticut Children's
- Study coordinator: Jacob Kelner
- Email: jkelner@connecticutchildrens.org
- Phone: 860-545-9720
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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LISA versus endotracheal surfactant distribution in preterm babies
This pilot trial tests whether giving surfactant through a thin catheter (LISA) or through a breathing tube leads to more even surfactant spread in preterm infants with respiratory distress.
-
Lung ultrasound score to guide surfactant timing in preterm newborns
This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.
-
Family-integrated newborn care for preterm and low-birth-weight babies
This project will try training and integrating parents into hospital care for preterm and low-birth-weight newborns in Tigray to see if it shortens hospital stays and improves outcomes.
-
Predicting which newborns in a lower-level NICU will need extended breathing support
This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.
-
Optimising breathing support at extubation for very preterm infants
This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.
-
Evaluating lung ultrasound after surfactant treatments in preterm babies
This study tests how different ways of giving surfactant treatment affect lung health in preterm babies with breathing problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.