Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-14 @ 6:41 AM
Study NCT ID:
NCT04086095
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2019-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study - Neofact
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Premature babies with Respiratory Distress Syndrome and the medical need for surfactant administration (defined as FiO2 ≥ 0.3 or mod. Silverman Andersen Respiratory Severity Score ≥ 5) while treated with CPAP-support and in a gestational age \\>26+0 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility of the application aid Neofact', 'timeFrame': 'Administration of surfactant + 30 minutes', 'description': 'Feasibility will be defined as a correct intratracheal position of the catheter (visually controlled via videolaryngoscope) OR responsiveness of the child to the surfactant administration (defined as decrease of the fraction of inspired oxygen (FiO2) of at least 0.05 within 30 minutes after the application OR FiO2 decrease to 0.21 with simultaneous improvement of the modified Silverman Andersen Respiratory Severity Score (RSS) ≥ 2 within 30 minutes after the application) without switching to a conventional LISA method\n\nRSS in the modified version of McAdams RM et al. The RSS consists of 5 categories that assess the respiratory work of the child in a range from 0 to 2 in each category. This results in a summarized score of 0 to 10, in which 0 defines a healthy neonate without increased work of breathing and 10 a neonate with maximum respiratory distress.'}], 'secondaryOutcomes': [{'measure': 'Duration of the surfactant administration procedure', 'timeFrame': 'up to 20 minutes', 'description': 'Measured time from the beginning of the initial insertion of the laryngoscope (plate tip passes the lips) to the removal of the application aid Neofact (Neofact tip passes the lips).'}, {'measure': 'Duration of the laryngoscopy', 'timeFrame': 'up to 15 minutes', 'description': 'Measured time from the beginning of the initial insertion of the laryngoscope (plate tip passes the lips) to the removal of the laryngoscope (plate tip passes the lips).'}, {'measure': 'Need for intubation and mechanical ventilation', 'timeFrame': '48 hours after administration', 'description': 'Number of neonates that need intubation and mechanical ventilation in the observational period of 48 hours after surfactant administration'}, {'measure': 'Number of attempts needed for the correct application', 'timeFrame': 'during application procedure', 'description': 'to evaluate how good the handling of the application aid will be'}, {'measure': 'Occurrence of complications', 'timeFrame': 'during application procedure', 'description': 'Number of decreases of oxygen saturation (\\< 80% SpO2), bradycardia (\\< 80 / min), tachycardia (\\> 200 / min), arterial hypo- (middle arterial blood pressure \\< Gestational Age (GA)) or hypertension (middle arterial blood pressure \\> GA + 20), onset and / or severity of coughing, choking, apnea \\& laryngospasm during the procedure'}, {'measure': 'Colonization of the catheter tip', 'timeFrame': 'up to 20 minutes', 'description': 'Name of germs and their number of colony forming units (CFU) placed on the catheter tip. To evaluate if there is a risk of contamination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Distress Syndrome', 'Less Invasive Surfactant Administration', 'Neofact', 'Preterm babies'], 'conditions': ['Respiratory Distress Syndrome in Premature Infant', 'Surfactant Deficiency Syndrome Neonatal']}, 'referencesModule': {'references': [{'pmid': '10224173', 'type': 'BACKGROUND', 'citation': 'Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7. doi: 10.1542/peds.103.5.961.'}, {'pmid': '15173537', 'type': 'BACKGROUND', 'citation': "Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Early extubation and nasal continuous positive airway pressure after surfactant treatment for respiratory distress syndrome among preterm infants <30 weeks' gestation. Pediatrics. 2004 Jun;113(6):e560-3. doi: 10.1542/peds.113.6.e560."}, {'pmid': '18272893', 'type': 'BACKGROUND', 'citation': 'Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.'}, {'pmid': '27842300', 'type': 'BACKGROUND', 'citation': 'Maiwald CA, Neuberger P, Vochem M, Poets C. QuickSF: A New Technique in Surfactant Administration. Neonatology. 2017;111(3):211-213. doi: 10.1159/000450823. Epub 2016 Nov 15.'}, {'pmid': '25389349', 'type': 'BACKGROUND', 'citation': 'McAdams RM, Hedstrom AB, DiBlasi RM, Mant JE, Nyonyintono J, Otai CD, Lester DA, Batra M. Implementation of Bubble CPAP in a Rural Ugandan Neonatal ICU. Respir Care. 2015 Mar;60(3):437-45. doi: 10.4187/respcare.03438. Epub 2014 Nov 11.'}, {'pmid': '32429874', 'type': 'DERIVED', 'citation': 'Maiwald CA, Dick J, Marschal M, Gille C, Franz AR, Poets CF. Microbiological analyses of nasally guided catheters after less invasive surfactant administration - a pilot study. BMC Pediatr. 2020 May 19;20(1):234. doi: 10.1186/s12887-020-02147-0.'}]}, 'descriptionModule': {'briefSummary': "For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung.\n\nIn the recent years, several methods have been developed. The methods differ in the selected ventilation mode (intubation with mechanical ventilation vs. Continous Positive Airway Pressure (CPAP)-supported spontaneous breathing) and in the way in which the application of surfactant is technically conducted (via endotracheal tube, endotracheal catheter or nebulization).\n\nIn selection of ventilation technique, there is an upcoming trend towards less invasive respiratory support via CPAP. While this may increase the rate of complications on the one side (i.e. pneumothorax), it shows much lower oxygen demand and a shorter need for mechanical ventilation on the other side.\n\nIn the selection of the administration technique, different methods were repeatedly developed to adapt the surfactant administration to the CPAP therapy. In this study, a newly developed and in the European Community now certified (CE-Mark) application aid (Neofact) will be tested for the first time on preterm infants, to verify the feasibility."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants with respiratory distress syndrome and the need for Surfactant administration (oxygen requirement with FiO2 ≥ 30% and/or mod. Silverman Andersen Respiratory Severity Score (RSS) ≥ 5)\n* Respiratory support with non-invasive CPAP at the time of Surfactant administration\n\nExclusion Criteria:\n\n* Preterms with an gestational age \\< 26+0 weeks\n* Preterms with malformations of the respiratory tract\n* Clinical decision on intubation / surfactant application via endotracheal tube e.g. because of respiratory drive disorder\n* (Missing parental consent)\n* (Attending physician is not delegated by the principal investigator)'}, 'identificationModule': {'nctId': 'NCT04086095', 'briefTitle': 'Feasibility Study - Neofact', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Feasibility Study - Neofact Feasibility Study of the Application Aid Neofact (Formerly: QuickSF) in the Less Invasive Surfactant Administration (LISA) in Premature Infants With Respiratory Distress Syndrome.', 'orgStudyIdInfo': {'id': 'feasibility study - Neofact'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Surfactant administration will be done via videolaryngoscopy and the application aid Neofact in neonates with respiratory distress syndrome and airway support with CPAP. Alveofact is used as Surfactant in its standard dosage of 100 mg / kg', 'interventionNames': ['Device: Neofact application aid']}], 'interventions': [{'name': 'Neofact application aid', 'type': 'DEVICE', 'description': 'The Neofact application aid is a specifically for the LISA procedure designed guide of a soft catheter and replaces the Magill forceps. Catheter (3.5 Fr.) and guide are already combined and packed together sterile. The catheter tip is marked in black (1cm).', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70176', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinikum Stuttgart - Olgahospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Christian A. Maiwald, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neonatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum Stuttgart', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}