Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration

NCT07442669 | Not Yet Recruiting DMC

• 1 other identifier: Pro2025-0038
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Respiratory Distress; Lung ultrasound; Surfactant Administration

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  First 5 days of life

• Duration of respiratory support during NICU hospitalization

  Duration of respiratory support during NICU stay, up to 100 days

• Duration of supplemental oxygen administration

  Duration of receiving supplemental oxygen during NICU stay, up to 100 days

Study Arms (2)

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.

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.

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Lung ultrasounds informing the decision-making on the Surfactant Administration

Lung Ultrasound (LUS)

Eligibility Criteria

• Age: 27 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandy Cheung, DO

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Buljevich Haugh

CONTACT

5519963457; jeanette.haugh@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): July 5, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)