Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT05331235
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2022-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Transfusions in Preterm Infants
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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'immediately before and immediately after blood transfusion', 'description': 'Heart rate per minute'}, {'measure': 'Change in respiratory rate', 'timeFrame': 'immediately before and immediately after blood transfusion', 'description': 'Respiratory rate per minute'}, {'measure': 'Change in weight gain', 'timeFrame': 'within 4 days before and within 4 days after blood transfusion', 'description': 'Average weight gain in grams/kg/day'}, {'measure': 'Change in hemoglobin', 'timeFrame': 'immediately before and immediately after blood transfusion', 'description': 'Hemoglobin in grams/dl'}, {'measure': 'Change in hematocrit value', 'timeFrame': 'immediately before and immediately after blood transfusion', 'description': 'Hematocrit value percentage'}], 'secondaryOutcomes': [{'measure': 'Acute blood loss', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': 'Acute blood loss either spontaneous or iatrogenic during invasive procedures'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': 'Mechanical ventilation (MV) which may be one of two possibilities:\n\n1. Moderate or significant MV; Mean airway pressure (MAP) \\>8 cm H2O on conventional ventilator or \\>14 cm H2O on high frequency ventilator and FiO2 \\>0.4\n2. Minimal MV; MAP ≤8 cmH2O on conventional ventilator or ≤14 cm H2O on high frequency ventilator and FiO2 ≤ 0.4'}, {'measure': 'Supplemental oxygen', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': 'Supplemental oxygen, not mechanically ventilated'}, {'measure': 'Doubling of oxygen requirements', 'timeFrame': 'in the previous 2 days before blood transfusion', 'description': 'Doubling of oxygen requirements for patients on supplemental oxygen'}, {'measure': 'Tachycardia', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': '≥24 hours of tachycardia (Heart rate\\>180/minute)'}, {'measure': 'Tachypnea', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': '≥24 hours of tachypnea (Respiratory rate\\>60/minute),'}, {'measure': 'Poor weight gain', 'timeFrame': 'in the previous 4 days before blood transfusion', 'description': '≤10 g/kg/day while the infant is receiving ≥120 kcal/kg/day'}, {'measure': 'Metabolic acidosis', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': 'pH \\<7.2'}, {'measure': 'Apnea and bradycardia', 'timeFrame': 'in the previous 24 hours before blood transfusion', 'description': '9 episodes or ≥2 episodes requiring bag and mask ventilation, while infant is receiving caffeine citrate'}, {'measure': 'Length of stay in the NICU', 'timeFrame': 'from date of birth until the date of transfer to the "grower ward" or date of death from any cause, whichever came first, assessed up to 3 months.', 'description': 'Length of stay in the NICU'}, {'measure': 'Length of stay in the hospital', 'timeFrame': 'from date of birth until the date of discharge home or date of death from any cause, whichever came first, assessed up to 3 months.', 'description': 'Length of stay in the hospital'}, {'measure': 'Mortality', 'timeFrame': 'from the date of transfer to grower ward, assessed up to 3 months.', 'description': 'Death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Red Blood Cells', 'Preterm']}, 'descriptionModule': {'briefSummary': 'A cross sectional study to assess the effect of blood transfusions on the outcome of preterm infants', 'detailedDescription': 'This is a cross sectional study carried on preterm infants who are staying in the hospital as "growers"; to gain weight. We will assess blood transfusion received by these preterm infants in details.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants admitted to the "grower ward", directly after birth or after transfer from NICU', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grower preterm infants\n\nExclusion Criteria:\n\n* Severe illness, Hypovolemic shock, Hypoxia, Oxygen therapy, Surgical intervention'}, 'identificationModule': {'nctId': 'NCT05331235', 'briefTitle': 'Blood Transfusions in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Effect of Blood Transfusions on the Outcome of Low Birth Weight Preterm Infants', 'orgStudyIdInfo': {'id': 'MS-49-2020'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Douaa El Sherbiny, MD', 'role': 'CONTACT', 'email': 'doaa.sherbiny@gmail.com', 'phone': '01000039725'}], 'overallOfficials': [{'name': 'Dahlia El Sebaie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasralainy hospital, Faculty of medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatrics, Cairo university', 'investigatorFullName': 'Douaa El Saied El Sherbiny', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}