Respiratory Distress Syndrome, NewbornNCT07442669
Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
A study testing Lung ultrasound in people with Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. Read more about this study
- Who is it for?
- Ages 27 to 34 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to 17 Aug 2028
- 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 27 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn at 27 0/7 to 34 6/7 weeks of gestational age
- Spontaneously breathing at birth but requiring non-invasive respiratory support
- RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS
Who cannot join
- Outborn
- Endotracheal intubation in the delivery room or within 2 hours of life
- Surfactant in the delivery room as part of advanced resuscitation
- Presence of major congenital malformations or chromosomal anomalies
- Hydrops fetalis
- Inherited disorders of metabolism
- Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome
- Infants in extremis not expected to survive
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
Hackensack Univeristy Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study
This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls.
The primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen.
The study population includes infants born between 27 and 34 6/7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.
Read the detailed description
Respiratory distress syndrome (RDS) is a frequently diagnosed disorder in premature infants admitted to the neonatal intensive care unit (NICU). It is caused by pulmonary immaturity and surfactant deficiency that result in increased alveolar collapse, mismatched ventilation-perfusion and ultimately hypoxia in neonates. Historically, early administration of exogenous surfactant via endotracheal tube has become the mainstay treatment and management of RDS. However, studies have shown neonates receiving invasive mechanical ventilation have higher incidence of developing bronchopulmonary dysplasia (BPD), causing a recent shift to increased use of non-invasive respiratory support for management of RDS. The use of early nasal ventilation and increasing mean airway pressure to improve alveolar stability and functional residual capacity (FRC) helps to improve fraction of inspired oxygen (FiO2) requirements even in the surfactant-deficient infant. This creates a dilemma for neonatologists. It is challenging to determine the severity of RDS in the first hours of life. Current standard is to use a combination of supplemental FiO2 requirement, work of breathing and chest x-ray to assess the need for surfactant replacement therapy (SRT) because there is a subset of infants who will fail non-invasive support and require intubation. Even with improvement in non-invasive RDS management, predicting surfactant deficiency before the deterioration of neonate would allow for earlier SRT and likely improve respiratory outcomes.
Point of care ultrasound (POCUS) is a common modality used in emergency medicine and is a rapidly emerging area of clinical research in neonatal medicine. Lung ultrasound has been shown to provide quick, reliable information via a noninvasive bedside technique in dynamically changing lungs. POCUS in neonatology has been shown to diagnose RDS earlier than waiting for chest x-ray and clinical changes. Studies have shown ultrasound can identify surfactant deficiency before clinical deterioration and decrease need for mechanical ventilation.
With this study, it is proposed to use lung ultrasound with a calculated lung ultrasound score (LUS) to assess severity of RDS and identify surfactant deficiency earlier than current practice of using supplemental FiO2 requirement and clinical status. This will allow earlier SRT, potentially improving short term respiratory outcomes and possibly longer term such as BPD. Similarly, it is proposed to investigate the potential synergy of early SRT using lung ultrasound and non-invasive administration of surfactant in positively impacting respiratory outcomes in moderately preterm and late preterm infants.
- Being tested
- Lung ultrasound
- Keywords
- Respiratory Distress, Lung ultrasound, Surfactant Administration
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Lung ultrasounds informing the decision-making on the Surfactant Administration
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound (LUS) | Experimental | The lung ultrasound will be performed within 2 hours of life scanning 6 anatomic lung zones. The lung ultrasound (LUS) score will be calculated in a longitudinal and transverse scan by dividing each lung into 3 different areas: upper-anterior, lower-anterior, and lateral. Every lung section will be scored 0-3 points. The total LUS score will range from 0 to 18 points according to the severity of the lung pattern. Examinations will be performed in the supine position. Lung ultrasound scores will be performed by neonatologist-researchers. A LUS score of 6 in < 28 week gestation and 8 in > 28 week gestation is the cut-off for initiating surfactant treatment. If the LUS score is > 6 in neonates < 28 weeks gestation, or > 8 in those > 28 weeks gestation, surfactant treatment will be administered. If a neonate in the LUS group does not meet criteria for SRT based on the lung ultrasound score, SRT may be administered per the clinician's discretion at any time. Receives: Diagnostic Test: Lung ultrasound |
| Standard of care (SOC) | No intervention | The standard of care group may have surfactant administered per clinician discretion. Standard diagnostic testing including CXR and blood gas will be performed per SOC. Current accepted practice in the NICU is to utilize a composite of chest x-ray interpretation, assessment of work of breathing, degree of respiratory support and FiO2 requirement (typically Fi02 35%) to guide SRT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Lung Ultrasound
To assess the feasibility of the lung ultrasound, this metric measures the elapsed time from birth to the administration of the lung ultrasound.
Measured: From date of birth to until the date/time of the lung ultrasound or date of death from any cause, assessed up to 1 week of life
Time to surfactant administration via LISA method
Neonates who underwent evaluation with lung ultrasound and received a LUS of 6 or greater in < 28 week gestation and total LUS of 8 or greater in > 28 week gestation will receive exogenous surfactant via the LISA method. The time to surfactant administration will be calculated from time of birth to time receiving therapy in hours.
Measured: From date of birth to until the date/time of first documented progression (surfactant administration) or date of death from any cause, assessed up to 1 week of life
Secondary outcomes (3)
Need for mechanical ventilation during first 5 days
Neonates will be followed during NICU stay and evaluate if neonates require intubation for mechanical ventilation during the first 5 days of life. This metric will be a binary outcome with "Yes" for neonates that required mechanical ventilation during the first 5 days of life and "No" for neonates that did not require mechanical ventilation or received mechanical ventilation after the 5 day period. The first 5 days of life will be defined as ≤ 120 hours.
Measured: First 5 days of life
Duration of respiratory support during NICU hospitalization
Neonates will be followed during NICU stay and duration of respiratory support (invasive and non-invasive defined as greater than 1L flow) will be calculated by the start of respiratory support until discontinuation of all respiratory support for a 24-hour period.
Measured: Duration of respiratory support during NICU stay, up to 100 days
Duration of supplemental oxygen administration
The preterm neonates admitted to NICU with confirmed diagnosis of RDS and received surfactant administration will be followed during the remainder of NICU stay. The duration of supplemental oxygen administration will be calculated from the start of receiving supplemental oxygen to until discontinuation supplemental oxygen administration for a 24-hour period.
Measured: Duration of receiving supplemental oxygen during NICU stay, up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start18 Aug 2026
- Primary completion17 Aug 2028 (estimated)
- Study completion17 Aug 2028 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandy Cheung, DO, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442669
- Sponsor's protocol ID
- Pro2025-0038
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study
- ClinicalTrials.gov ID
- NCT07442669
- Acronym / sponsor ID
- Pro2025-0038
- Keywords
- Respiratory Distress, Lung ultrasound, Surfactant Administration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 17 Aug 2028 (estimated)
- Study completion
- 17 Aug 2028 (estimated)
- First posted
- 2 Mar 2026 (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.
This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls.
The primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen.
The study population includes infants born between 27 and 34 6/7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.
Detailed description
Respiratory distress syndrome (RDS) is a frequently diagnosed disorder in premature infants admitted to the neonatal intensive care unit (NICU). It is caused by pulmonary immaturity and surfactant deficiency that result in increased alveolar collapse, mismatched ventilation-perfusion and ultimately hypoxia in neonates. Historically, early administration of exogenous surfactant via endotracheal tube has become the mainstay treatment and management of RDS. However, studies have shown neonates receiving invasive mechanical ventilation have higher incidence of developing bronchopulmonary dysplasia (BPD), causing a recent shift to increased use of non-invasive respiratory support for management of RDS. The use of early nasal ventilation and increasing mean airway pressure to improve alveolar stability and functional residual capacity (FRC) helps to improve fraction of inspired oxygen (FiO2) requirements even in the surfactant-deficient infant. This creates a dilemma for neonatologists. It is challenging to determine the severity of RDS in the first hours of life. Current standard is to use a combination of supplemental FiO2 requirement, work of breathing and chest x-ray to assess the need for surfactant replacement therapy (SRT) because there is a subset of infants who will fail non-invasive support and require intubation. Even with improvement in non-invasive RDS management, predicting surfactant deficiency before the deterioration of neonate would allow for earlier SRT and likely improve respiratory outcomes.
Point of care ultrasound (POCUS) is a common modality used in emergency medicine and is a rapidly emerging area of clinical research in neonatal medicine. Lung ultrasound has been shown to provide quick, reliable information via a noninvasive bedside technique in dynamically changing lungs. POCUS in neonatology has been shown to diagnose RDS earlier than waiting for chest x-ray and clinical changes. Studies have shown ultrasound can identify surfactant deficiency before clinical deterioration and decrease need for mechanical ventilation.
With this study, it is proposed to use lung ultrasound with a calculated lung ultrasound score (LUS) to assess severity of RDS and identify surfactant deficiency earlier than current practice of using supplemental FiO2 requirement and clinical status. This will allow earlier SRT, potentially improving short term respiratory outcomes and possibly longer term such as BPD. Similarly, it is proposed to investigate the potential synergy of early SRT using lung ultrasound and non-invasive administration of surfactant in positively impacting respiratory outcomes in moderately preterm and late preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound (LUS) | Experimental | Diagnostic Test: Lung ultrasoundThe lung ultrasound will be performed within 2 hours of life scanning 6 anatomic lung zones. The lung ultrasound (LUS) score will be calculated in a longitudinal and transverse scan by dividing each lung into 3 different areas: upper-anterior, lower-anterior, and lateral. Every lung section will be scored 0-3 points. The total LUS score will range from 0 to 18 points according to the severity of the lung pattern. Examinations will be performed in the supine position. Lung ultrasound scores will be performed by neonatologist-researchers. A LUS score of 6 in < 28 week gestation and 8 in > 28 week gestation is the cut-off for initiating surfactant treatment. If the LUS score is > 6 in neonates < 28 weeks gestation, or > 8 in those > 28 weeks gestation, surfactant treatment will be administered. If a neonate in the LUS group does not meet criteria for SRT based on the lung ultrasound score, SRT may be administered per the clinician's discretion at any time. |
| Standard of care (SOC) | No intervention | –The standard of care group may have surfactant administered per clinician discretion. Standard diagnostic testing including CXR and blood gas will be performed per SOC. Current accepted practice in the NICU is to utilize a composite of chest x-ray interpretation, assessment of work of breathing, degree of respiratory support and FiO2 requirement (typically Fi02 35%) to guide SRT. |
Who may qualify
- Ages
- 27 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Inborn at 27 0/7 to 34 6/7 weeks of gestational age
- Spontaneously breathing at birth but requiring non-invasive respiratory support
- RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS
Key exclusion criteria (8 listed)
- Outborn
- Endotracheal intubation in the delivery room or within 2 hours of life
- Surfactant in the delivery room as part of advanced resuscitation
- Presence of major congenital malformations or chromosomal anomalies
- Hydrops fetalis
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 |
|---|---|---|
| Lung ultrasoundLung ultrasounds informing the decision-making on the Surfactant Administration | Diagnostic test | Lung Ultrasound (LUS) |
Primary outcome
Time to Lung Ultrasound
Time frame: From date of birth to until the date/time of the lung ultrasound or date of death from any cause, assessed up to 1 week of life
To assess the feasibility of the lung ultrasound, this metric measures the elapsed time from birth to the administration of the lung ultrasound.
Time to surfactant administration via LISA method
Time frame: From date of birth to until the date/time of first documented progression (surfactant administration) or date of death from any cause, assessed up to 1 week of life
Neonates who underwent evaluation with lung ultrasound and received a LUS of 6 or greater in < 28 week gestation and total LUS of 8 or greater in > 28 week gestation will receive exogenous surfactant via the LISA method. The time to surfactant administration will be calculated from time of birth to time receiving therapy in hours.
3 secondary outcomes
Need for mechanical ventilation during first 5 days
Time frame: First 5 days of life
Duration of respiratory support during NICU hospitalization
Time frame: Duration of respiratory support during NICU stay, up to 100 days
Duration of supplemental oxygen administration
Time frame: Duration of receiving supplemental oxygen during NICU stay, up to 100 days
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 19 Aug 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.
Sandy Cheung, DO principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound in people with Respiratory Distress Syndrome, Newborn and Respiratory Distress Syndrome in Premature Infant, run by Hackensack Meridian Health 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 8 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 19 Aug 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 Jeanette Buljevich Haugh (5519963457, jeanette.haugh@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Lung Ultrasound (time frame: From date of birth to until the date/time of the lung ultrasound or date of death from any cause, assessed up to 1 week of life). The study lists 2 primary outcomes in all. 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 19 Aug 2026.