Respiratory Distress Syndrome, NewbornNCT06446453
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
A study testing Echography-guided Surfactant THERapy (ESTHER) in people with Respiratory Distress Syndrome, Newborn and Pulmonary Surfactants, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants, Intensive Care Units, Neonatal
- What is being tested?
- Echography-guided Surfactant THERapy (ESTHER)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's
Hartford, Connecticut, 06106
Little
About this study
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
- Being tested
- Echography-guided Surfactant THERapy (ESTHER)
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echography-guided Surfactant THERapy (ESTHER)Diagnostic test
Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Treatment | Experimental | 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). Receives: Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation Index
(CPAP Level x FiO2)/(SpO2)
Measured: At 24 hours of life.
Secondary outcomes (1)
Oxygen Saturation Index
(CPAP Level x FiO2)/(SpO2)
Measured: At 48 and 72 hours of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start25 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob, Connecticut Children's Medical Center
- Investigators
- Jacob Kelner, Principal investigator, Connecticut Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446453
- Sponsor's protocol ID
- 24-005-CCMC
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
- ClinicalTrials.gov ID
- NCT06446453
- Acronym / sponsor ID
- 24-005-CCMC
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants, Intensive Care Units, Neonatal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Treatment | Experimental | Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)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). |
Who may qualify
- Ages
- 0 to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echography-guided Surfactant THERapy (ESTHER)Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score. | Diagnostic test | Treatment |
Primary outcome
Oxygen Saturation Index
Time frame: At 24 hours of life.
(CPAP Level x FiO2)/(SpO2)
1 secondary outcome
Oxygen Saturation Index
Time frame: At 48 and 72 hours of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Kelner principal investigator
Connecticut Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echography-guided Surfactant THERapy (ESTHER) in people with Respiratory Distress Syndrome, Newborn and Pulmonary Surfactants, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Kelner (860-545-9720, jkelner@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation Index (time frame: At 24 hours of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.