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

Conditions

• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

Eligibility Criteria

Sex

ALL

Age

27 Weeks - 34 Weeks

Healthy Volunteers

Not accepted

Interventions

• Lung ultrasound — DIAGNOSTIC_TEST
  Lung ultrasounds informing the decision-making on the Surfactant Administration

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

May 2026

Primary completion

Jun 28, 2028

Completion

Jul 5, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• Jeanette Buljevich Haugh
  5519963457
  [email protected]

Locations (1)

Find similar trials in Hackensack, NJ

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