[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07442669":3,"trial-entities:NCT07442669":103,"trial-summary:NCT07442669":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":47,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":79,"locations":81,"central_contacts":91,"overall_officials":97,"references":101,"see_also_links":102},"NCT07442669","Pro2025-0038","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study","RECRUITING","2028-08-17","2026-08","2026-08-19","2026-08-18","Hackensack Meridian Health","OTHER",true,"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.\n\nThe 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.\n\nThe study population includes infants born between 27 and 34 6\u002F7 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.","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.\n\nPoint 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.\n\nWith 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.",[19,20],"Respiratory Distress Syndrome, Newborn","Respiratory Distress Syndrome in Premature Infant",[22,23,24],"Respiratory Distress","Lung ultrasound","Surfactant Administration","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},100,"ESTIMATED",[33],{"type":34,"name":23,"description":35,"armGroupLabels":36},"DIAGNOSTIC_TEST","Lung ultrasounds informing the decision-making on the Surfactant Administration",[37],"Lung Ultrasound (LUS)",[39,43],{"measure":40,"description":41,"timeFrame":42},"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\u002Ftime of the lung ultrasound or date of death from any cause, assessed up to 1 week of life",{"measure":44,"description":45,"timeFrame":46},"Time to surfactant administration via LISA method","Neonates who underwent evaluation with lung ultrasound and received a LUS of 6 or greater in \\\u003C 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\u002Ftime of first documented progression (surfactant administration) or date of death from any cause, assessed up to 1 week of life",[48,52,56],{"measure":49,"description":50,"timeFrame":51},"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.","First 5 days of life",{"measure":53,"description":54,"timeFrame":55},"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.","Duration of respiratory support during NICU stay, up to 100 days",{"measure":57,"description":58,"timeFrame":59},"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.","Duration of receiving supplemental oxygen during NICU stay, up to 100 days","ALL","27 Weeks","34 Weeks",false,{"inclusion":65,"exclusion":69,"raw_text":78},[66,67,68],"Inborn at 27 0\u002F7 to 34 6\u002F7 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",[70,71,72,73,74,75,76,77],"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","Inclusion Criteria:\n\n* Inborn at 27 0\u002F7 to 34 6\u002F7 weeks of gestational age\n* Spontaneously breathing at birth but requiring non-invasive respiratory support\n* RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS\n\nExclusion Criteria:\n\n* Outborn\n* Endotracheal intubation in the delivery room or within 2 hours of life\n* Surfactant in the delivery room as part of advanced resuscitation\n* Presence of major congenital malformations or chromosomal anomalies\n* Hydrops fetalis\n* Inherited disorders of metabolism\n* Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome\n* Infants in extremis not expected to survive",[80],"CHILD",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Hackensack Univeristy Medical Center","Hackensack","New Jersey","07601","United States",{"lat":89,"lon":90},40.88593,-74.04347,[92],{"name":93,"role":94,"phone":95,"email":96},"Jeanette Buljevich Haugh","CONTACT","5519963457","jeanette.haugh@hmhn.org",[98],{"name":99,"affiliation":13,"role":100},"Sandy Cheung, DO","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Respiratory Distress Syndrome",[],{"nct_id":4,"found":15,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is a prospective randomized controlled study involving 100 infants. There will be 67 infants in the group receiving the lung ultrasound-guided care and 33 in a control group.","completed","Lung Ultrasound for Respiratory Distress Syndrome in Premature Infants","This study is looking at whether using a lung ultrasound score can help doctors decide more quickly when to give surfactant to premature babies with Respiratory Distress Syndrome (RDS). RDS is a common breathing problem in premature infants. The study will involve 100 infants born between 27 and 34 weeks of pregnancy who need breathing support and have RDS or are at risk for it. The main goal is to see if using lung ultrasound leads to faster surfactant administration. Researchers will also check if this approach improves how well babies breathe in the short term, such as reducing the need for breathing machines or oxygen. This study is currently recruiting participants.","The primary outcomes, like time to lung ultrasound and time to surfactant administration, are assessed up to 1 week of life.",112,"Not specified in the trial record.","Not stated in the trial record.",[23],"v2"]