Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06676904
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neonatal Platelet Transfusion Threshold Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'There will be no blinding/masking of the treatment group allocation to providers or parents to ensure providers are aware of treatment allocation to guide platelet transfusions. This is necessary to ensure adherence to the treatment arms. However, a standard tool will be used to assess bleeding as described below and grading of the severity of bleeding will be performed centrally. In addition, radiologists interpreting cranial ultrasound findings will be blinded to treatment arm allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial with 1:1 allocation to parallel arms within strata of Study Center and gestational age (23-24 weeks and 25-26 weeks PMA). Multiples will be randomized independently. Approximately 30% of enrolled participants are expected to meet the platelet count threshold for randomization. The target sample size for randomization is 730, or 365 per arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2433}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Late-onset sepsis', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)'}, {'measure': 'Necrotizing enterocolitis', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)', 'description': 'Modified Bells Stage IIA or greater'}, {'measure': 'Thrombosis requiring therapy', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)', 'description': 'Thrombosis requiring therapy such as heparin, enoxaparin, or aspirin'}], 'primaryOutcomes': [{'measure': 'Survival without major or severe bleeding', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)', 'description': 'Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': "Randomization to 52 0/7 weeks' postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first, per Neonatal Research Network Generic Research Database Registry protocol."}, {'measure': 'Major or severe bleeding', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)', 'description': 'Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)'}, {'measure': 'Number of platelet transfusions', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)'}, {'measure': 'At least one platelet transfusion', 'timeFrame': 'Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)'}, {'measure': 'Bronchopulmonary dysplasia among survivors to 36 weeks postmenstrual age', 'timeFrame': 'At 36 weeks postmenstrual age'}, {'measure': 'Retinopathy of Prematurity (ROP)', 'timeFrame': "Randomization to 52 0/7 weeks' postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first, per Neonatal Research Network Generic Research Database Registry protocol.", 'description': 'Stage 3 ROP, or stage 1 or 2 in Zone 1, or plus disease'}, {'measure': 'Periventricular leukomalacia', 'timeFrame': "Randomization to 52 0/7 weeks' postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first, per Neonatal Research Network Generic Research Database Registry protocol."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet transfusion', 'neonatal', 'thrombosis'], 'conditions': ['Thrombocytopenia', 'Neonatal', 'Platelet Transfusion', 'Infant, Newborn, Diseases', 'Infant, Extremely Low Birth Weight', 'Infant, Small for Gestational Age', 'Thrombosis']}, 'referencesModule': {'references': [{'pmid': '23144007', 'type': 'BACKGROUND', 'citation': 'Venkatesh V, Curley A, Khan R, Clarke P, Watts T, Josephson C, Muthukumar P, New H, Seeney F, Morris S, Stanworth S. A novel approach to standardised recording of bleeding in a high risk neonatal population. Arch Dis Child Fetal Neonatal Ed. 2013 May;98(3):F260-3. doi: 10.1136/archdischild-2012-302443. Epub 2012 Nov 9.'}]}, 'descriptionModule': {'briefSummary': "The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).", 'detailedDescription': "Thrombocytopenia, defined as a platelet count \\<150 x 10\\^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk.\n\nThe NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (\\<27 weeks GA). It will test whether a threshold of 20x10\\^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization.\n\nThis is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of \\< 50 x 10\\^9/L (postnatal days 1-7) or \\<35 x 10\\^9/L (8 or more postnatal days) will be randomized. Postnatal day 1 starts at birth. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age of 23 0/7 to 26 6/7 weeks\n* Postnatal age of \\< 48 hours\n\nExclusion Criteria:\n\n* Comfort care or withdrawal of care planned\n* Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder\n* Receipt of platelet transfusion\n* No receipt of Vitamin K\n* Parents/guardian decline consent'}, 'identificationModule': {'nctId': 'NCT06676904', 'acronym': 'NeoPlaTT', 'briefTitle': 'Neonatal Platelet Transfusion Threshold Trial', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Neonatal Platelet Transfusion Threshold Trial', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0065'}, 'secondaryIdInfos': [{'id': '1U24HL173304-01', 'link': 'https://reporter.nih.gov/quickSearch/1U24HL173304-01', 'type': 'NIH'}, {'id': 'UG3HL173303', 'link': 'https://reporter.nih.gov/quickSearch/UG3HL173303', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Higher Platelet Transfusion Threshold', 'description': 'Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.', 'interventionNames': ['Procedure: Higher Platelet Transfusion Threshold']}, {'type': 'OTHER', 'label': 'Lower Platelet Transfusion Threshold', 'description': 'Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.', 'interventionNames': ['Procedure: Lower Platelet Transfusion Threshold']}], 'interventions': [{'name': 'Higher Platelet Transfusion Threshold', 'type': 'PROCEDURE', 'otherNames': ['Liberal Transfusion Threshold'], 'description': 'Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.', 'armGroupLabels': ['Higher Platelet Transfusion Threshold']}, {'name': 'Lower Platelet Transfusion Threshold', 'type': 'PROCEDURE', 'otherNames': ['Restrictive Transfusion Threshold'], 'description': 'Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.', 'armGroupLabels': ['Lower Platelet Transfusion Threshold']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Waldemar A Carlo, MD', 'role': 'CONTACT'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Valerie Chock, MD', 'role': 'CONTACT'}, {'name': 'Valerie Chock, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anup Katheria, MD', 'role': 'CONTACT'}, {'name': 'Anup Katheria, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sharp Mary Birch Hospital for Women & Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sunah Hwang, MD', 'role': 'CONTACT'}, {'name': 'Sunah Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ravi Patel, MD', 'role': 'CONTACT'}, {'name': 'Brenda Poindexter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ravi Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Hamvas, MD', 'role': 'CONTACT'}, {'name': 'Aaron Hamvas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Northwestern Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tarah Colaizy, MD, MPH', 'role': 'CONTACT', 'phone': '319-356-3508'}, {'name': 'Edward F. Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Helen Healy, MD', 'role': 'CONTACT'}, {'name': 'Helen Healy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janell Fuller, MD', 'role': 'CONTACT'}, {'name': 'Janell Fuller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': "Carl T D'Angio, MD", 'role': 'CONTACT'}, {'name': "Carl T D'Angio, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Cotten, MD', 'role': 'CONTACT'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Merhar, MD MS', 'role': 'CONTACT'}, {'name': 'Vivek Narendran, MD, MBA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephanie Merhar, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Maria Hibbs, MD', 'role': 'CONTACT'}, {'name': 'Anna Maria Hibbs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Case Western Reserve University, Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pablo Sanchez, MD', 'role': 'CONTACT'}, {'name': 'Pablo Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara DeMauro, MD', 'role': 'CONTACT'}, {'name': 'Sara DeMauro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hendrick Weitkamp, MD', 'role': 'CONTACT'}, {'name': 'Hendrick Weitkamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Myra Myckoff, MD', 'role': 'CONTACT'}, {'name': 'Myra Wyckoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jon Tyson', 'role': 'CONTACT'}, {'name': 'Jon Tyson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaashif Ahmad, MD', 'role': 'CONTACT'}, {'name': 'Kaashif Ahmad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pediatrix Medical Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robin Ohls, MD', 'role': 'CONTACT'}, {'name': 'Robin Ohls, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Ravi M Patel, MD', 'role': 'CONTACT', 'email': 'rmpatel@emory.edu', 'phone': '404-727-5905'}, {'name': 'Abhik Das, PhD', 'role': 'CONTACT', 'email': 'adas@rti.org', 'phone': '301-230-4640'}], 'overallOfficials': [{'name': 'Ravi M Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}