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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome

NCT04775459

Preterm Birth

COMPLETED

Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.

NCT06491901

Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants

NOT_YET_RECRUITING NA

Lung Ultrasound - Prospective Study

NCT06140615

Respiratory Distress of Newborn

RECRUITING NA

Lung Ultrasound to Guide Surfactant Therapy

NCT04330443

Respiratory Distress Syndrome

COMPLETED NA

Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)

NCT05198375

Respiratory Distress Syndrome, Newborn

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Echography-guided Surfactant THERapy (ESTHER)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echography-guided Surfactant THERapy (ESTHER)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No