Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT05782569
Status:
UNKNOWN
Last Update Posted:
2023-03-23
First Post:
2023-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serial Lung Ultrasound Predicting Need for Surfactant and Respiratory Course in Preterm Infants Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-03-22', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of chest/Lung ultrasound (LU) to predict the need for surfactant in preterm population.', 'timeFrame': '3 hours of age', 'description': 'Lung ultrasound scores within the first 3 hours of life to predict the need for 1st Dose of surfactant'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Babies born under 34 weeks', 'Risk of developing lung problems after birth'], 'conditions': ['Infant, Premature']}, 'referencesModule': {'references': [{'pmid': '40407825', 'type': 'DERIVED', 'citation': 'Loganathan PK, Meau-Petit V, Bhojnagarwala B, Nair V, Holmes J, Occhipinti A, Montasser M. Serial lung ultrasound in predicting the need for surfactant and respiratory course in preterm infants-multicentre observational study (SLURP). Eur J Pediatr. 2025 May 23;184(6):356. doi: 10.1007/s00431-025-06185-7.'}]}, 'descriptionModule': {'briefSummary': "Babies born early (under 34 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed (lung immaturity). One of the important components not yet produced by the lungs is the surfactant, which allows premature babies to breathe without much effort. Very often babies born early need some help with their breathing and also need surfactant. Surfactant is administered through a breathing tube which is placed into the baby's airway. It is important that surfactant is administered early after birth when the baby cannot produce it. Early administration of surfactant provides better clinical outcomes.\n\nCurrently the decision to give surfactant is based on clinical parameters such as the level of oxygen that your baby requires. Current strategy of waiting for the baby to reach certain oxygen level, may delay in administering surfactant. But recent scientific data from other countries suggest that ultrasound of the chest/lungs can predict early which babies would need surfactant. This would help us to administer surfactant earlier and improve their respiratory outcome. In this study, we want to confirm the value of chest/Lung ultrasound (LU) to predict the need for surfactant in UK population. As a part of the study, we will perform early LU and serial LU in the first few days of life. In this current study, LU images will only be recorded and not used for clinical management.", 'detailedDescription': 'Participant group for the study: Babies born under 34 weeks with a risk of developing lung problems after birth.\n\nThis study is an observational study to confirm the value of chest/Lung ultrasound (LU) to predict the need for surfactant in UK newborn population. As a part of the study, the investigators will perform early LU and serial LU in the first few days of life.\n\nThe investigators will perform the first LU within 3 hours of admission. A Second LU will then be taken at 3-6 hours after surfactant administration (if the baby receives surfactant) or at 6-12 hours of life (if the baby continues to be on Non-invasive respiratory support). A third LU is then taken on Day 2 (12-24 hours after the second LU) and a fourth LU on Day 3 (12-24 hours after the third LU). Then the investigators will carry out additional clinical data collection at hospital discharge.\n\nUltrasound is a common procedure carried out in newborn population. The scan should not take more than 3 to 5 minutes. All other data would be obtained from patient notes and databases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '23 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruiting the neonatal (Newborn) population. Currently there is no definite way of identifying which infant would need surfactant so this research would study study the value of lung ultrasound in predicting which infant would benefit from surfactant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age ≤34 weeks based on last menstrual period or ultrasound dating.\n2. Non-invasive respiratory support or low flow oxygen needing neonatal unit admission\n\nExclusion Criteria:\n\n1. Received surfactant before first LU (\\<3hrs of life).\n2. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.\n3. Infants receiving delivery room surfactant or required intubation shortly after admission.\n4. Infants diagnosed with pneumothorax needing needle or chest tube drainage'}, 'identificationModule': {'nctId': 'NCT05782569', 'acronym': 'SLURP', 'briefTitle': 'Serial Lung Ultrasound Predicting Need for Surfactant and Respiratory Course in Preterm Infants Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'South Tees Hospitals NHS Foundation Trust'}, 'officialTitle': 'Serial Lung Ultrasound in Predicting the Need for Surfactant and Respiratory Course in Preterm Infants - Observational Study (SLURP)', 'orgStudyIdInfo': {'id': 'PRENET 2297'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jane Greenaway', 'role': 'CONTACT', 'email': 'tvra.projects@nhs.net', 'phone': '01642850850'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Tees Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}