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

RecruitingNA

Sponsor: Hackensack Meridian Health

Conditions: Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant

Interventions: Lung ultrasound

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 27 Weeks to 34 Weeks

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Hackensack, New Jersey, United States