Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age27-34
SponsorHackensack Meridian Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lung ultrasound
Diagnostic testLung ultrasounds informing the decision-making on the Surfactant Administration
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Lung Ultrasound (LUS)Experimental treatment 1 intervention
Group B: Standard of care (SOC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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 life2
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.
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 lifeSecondary outcomes
1
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.
Time frame
First 5 days of life2
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.
Time frame
Duration of respiratory support during NICU stay, up to 100 days3
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.
Time frame
Duration of receiving supplemental oxygen during NICU stay, up to 100 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov