Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung ultrasound.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant. Basic parameters: 27 Weeks — 34 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study
Overview
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.
Detailed description
Respiratory distress syndrome (RDS) is a frequently diagnosed disorder in premature infants admitted to the neonatal intensive care unit (NICU). It is caused by pulmonary immaturity and surfactant deficiency that result in increased alveolar collapse, mismatched ventilation-perfusion and ultimately hypoxia in neonates. Historically, early administration of exogenous surfactant via endotracheal tube has become the mainstay treatment and management of RDS. However, studies have shown neonates receiving invasive mechanical ventilation have higher incidence of developing bronchopulmonary dysplasia (BPD), causing a recent shift to increased use of non-invasive respiratory support for management of RDS. The use of early nasal ventilation and increasing mean airway pressure to improve alveolar stability and functional residual capacity (FRC) helps to improve fraction of inspired oxygen (FiO2) requirements even in the surfactant-deficient infant. This creates a dilemma for neonatologists. It is challenging to determine the severity of RDS in the first hours of life. Current standard is to use a combination of supplemental FiO2 requirement, work of breathing and chest x-ray to assess the need for surfactant replacement therapy (SRT) because there is a subset of infants who will fail non-invasive support and require intubation. Even with improvement in non-invasive RDS management, predicting surfactant deficiency before the deterioration of neonate would allow for earlier SRT and likely improve respiratory outcomes.
Point of care ultrasound (POCUS) is a common modality used in emergency medicine and is a rapidly emerging area of clinical research in neonatal medicine. Lung ultrasound has been shown to provide quick, reliable information via a noninvasive bedside technique in dynamically changing lungs. POCUS in neonatology has been shown to diagnose RDS earlier than waiting for chest x-ray and clinical changes. Studies have shown ultrasound can identify surfactant deficiency before clinical deterioration and decrease need for mechanical ventilation.
With this study, it is proposed to use lung ultrasound with a calculated lung ultrasound score (LUS) to assess severity of RDS and identify surfactant deficiency earlier than current practice of using supplemental FiO2 requirement and clinical status. This will allow earlier SRT, potentially improving short term respiratory outcomes and possibly longer term such as BPD. Similarly, it is proposed to investigate the potential synergy of early SRT using lung ultrasound and non-invasive administration of surfactant in positively impacting respiratory outcomes in moderately preterm and late preterm infants.
Interventions
- Diagnostic test Lung ultrasound
Lung ultrasounds informing the decision-making on the Surfactant Administration
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Need for mechanical ventilation during first 5 days [Time frame: First 5 days of life]
- Duration of respiratory support during NICU hospitalization [Time frame: Duration of respiratory support during NICU stay, up to 100 days]
- Duration of supplemental oxygen administration [Time frame: Duration of receiving supplemental oxygen during NICU stay, up to 100 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Hackensack Univeristy Medical Center — Hackensack
Identifiers
NCT: NCT07442669 · Pro2025-0038