Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:30 PM
Study NCT ID:
NCT07442669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Lung Ultrasound', 'timeFrame': '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', 'description': 'To assess the feasibility of the lung ultrasound, this metric measures the elapsed time from birth to the administration of the lung ultrasound.'}, {'measure': 'Time to surfactant administration via LISA method', 'timeFrame': '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', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Need for mechanical ventilation during first 5 days', 'timeFrame': 'First 5 days of life', 'description': '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.'}, {'measure': 'Duration of respiratory support during NICU hospitalization', 'timeFrame': 'Duration of respiratory support during NICU stay, up to 100 days', 'description': '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.'}, {'measure': 'Duration of supplemental oxygen administration', 'timeFrame': 'Duration of receiving supplemental oxygen during NICU stay, up to 100 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Distress', 'Lung ultrasound', 'Surfactant Administration'], 'conditions': ['Respiratory Distress Syndrome, Newborn', 'Respiratory Distress Syndrome in Premature Infant']}, 'descriptionModule': {'briefSummary': '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 6/7 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '27 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn at 27 0/7 to 34 6/7 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'}, 'identificationModule': {'nctId': 'NCT07442669', 'briefTitle': 'Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study', 'orgStudyIdInfo': {'id': 'Pro2025-0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung Ultrasound (LUS)', 'description': "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.", 'interventionNames': ['Diagnostic Test: Lung ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care (SOC)', 'description': '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.'}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung ultrasounds informing the decision-making on the Surfactant Administration', 'armGroupLabels': ['Lung Ultrasound (LUS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack Univeristy Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'centralContacts': [{'name': 'Jeanette Buljevich Haugh', 'role': 'CONTACT', 'email': 'jeanette.haugh@hmhn.org', 'phone': '5519963457'}], 'overallOfficials': [{'name': 'Sandy Cheung, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}