Recruiting

Lung Ultrasound

Sponsor:

Hackensack Meridian Health

Code:

NCT07442669

Conditions

Respiratory Distress Syndrome, Newborn

Respiratory Distress Syndrome in Premature Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Lung ultrasound

Study Details

Brief 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. 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.

Conditions

Respiratory Distress Syndrome, Newborn

Respiratory Distress Syndrome in Premature Infant

Study ID

NCT07442669

Start date

Aug 18, 2026

Status verified date

Aug, 2026

Completion date

Aug 17, 2028

Anticipated

Primary completion date

Aug 17, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lung Ultrasound (LUS)

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.

no intervention: Standard of care (SOC)

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.

Interventions

Lung ultrasound

Lung ultrasounds informing the decision-making on the Surfactant Administration

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jeanette Buljevich Haugh

5519963457jeanette.haugh@hmhn.org

Locations

Hackensack Univeristy Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Respiratory Distress
  • Lung ultrasound
  • Surfactant Administration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-08-19.