Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 3:36 AM
Study NCT ID:
NCT06884969
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late-onset Sepsis and Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peabody Developmental Motor Scales | Second Edition (PDMS-2)', 'timeFrame': '10-18 months', 'description': "Peabody Motor Development Scale-2 was planned to be used to evaluate motor development. Peabody Motor Development Scale-2 was designed to determine developmental delays in children between 0-72 months. Separate tests and rating scales for both gross motor skills and fine motor skills were used to evaluate children's motor development."}, {'measure': 'Test of Sensory Functions in Infants', 'timeFrame': '10-18 months', 'description': 'It was planned to use the Test of Sensory Function in Infants. The Test of Sensory Function in Infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The Test of Sensory Function in Infants requires the infant to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has normative values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'motor development', 'sensory processing skills', 'infant'], 'conditions': ['Sepsis Newborn', 'Motor Development', 'Sensory Integration Dysfunction']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Folio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.'}, {'type': 'BACKGROUND', 'citation': 'DeGangi, G.A. and S.I. Greenspan, The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics, 1989. 8(4): p. 21-33.'}, {'pmid': '15547163', 'type': 'BACKGROUND', 'citation': 'Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.'}, {'pmid': '22371459', 'type': 'BACKGROUND', 'citation': 'Greenhow TL, Hung YY, Herz AM. Changing epidemiology of bacteremia in infants aged 1 week to 3 months. Pediatrics. 2012 Mar;129(3):e590-6. doi: 10.1542/peds.2011-1546. Epub 2012 Feb 27.'}, {'pmid': '41175143', 'type': 'DERIVED', 'citation': 'Zorlular R, Degirmencioglu H, Zorlular A. Sensory processing and motor development in term infants following late-onset neonatal sepsis-a cross-sectional study. Eur J Pediatr. 2025 Nov 1;184(11):726. doi: 10.1007/s00431-025-06571-1.'}]}, 'descriptionModule': {'briefSummary': 'Neonatal sepsis is classified as early-onset and late-onset sepsis. Early-onset sepsis occurs within the first 72 hours after birth and is associated with a mortality rate of 10-15%. Late-onset sepsis, on the other hand, is characterized by its onset after the first 72 hours of life in infants who have been exposed to microorganisms in the postnatal environment. Preterm infants are the most vulnerable group in terms of sepsis, and the incidence of hospital-acquired late-onset sepsis can reach up to 40% in extremely preterm neonates. In contrast, community-acquired late-onset sepsis has been predominantly reported in late preterm and full-term infants. Community-acquired late-onset sepsis is the most common form of sepsis among term neonates and accounts for half of all sepsis episodes in infants born at ≥37 weeks of gestation.During infancy, particularly when children begin to crawl and walk, they actively explore their environment and attempt to expand their motor repertoire. However, when examining studies related to sepsis, it appears that assessments conducted during the walking infant period are quite limited, with most research focusing on school-aged and preschool children. Furthermore, existing studies primarily address behavioral problems and motor performance issues.Therefore, considering that this period represents an early stage of development, it is planned to include infants aged 10 to 18 months in the present study. The aim of this study is to evaluate the motor development and sensory processing skills of infants with a history of sepsis and to compare them with their healthy peers without a history of sepsis.', 'detailedDescription': 'Neonatal sepsis is a common condition that triggers both pro- and anti-inflammatory responses in the organism, affects various tissues, and alters enzymatic activities. Immaturity of the immune system, the use of central catheters during parenteral nutrition, and delayed enteral feeding with breast milk are well-known risk factors for late-onset sepsis in neonates. Late-onset sepsis is defined as sepsis that occurs after 72 hours of postnatal life and is characterized by infectious symptoms (such as fever, irritability, lethargy, apnea, growth retardation, feeding refusal, tachycardia, or tachypnea), the presence of acute phase reactants (elevated interleukin-6 or C-reactive protein), and/or positive blood culture and leukopenia criteria. The evaluation of sensory processing skills becomes crucial in children aged 10 to 18 months, a period when they begin to explore their environment through walking and trial-and-error learning. Motor development during this period largely depends on active trial-and-error learning, making effective sensory processing a critical component. However, the first two years of life, which represent the fastest and most critical period of development, have been largely neglected in terms of assessing motor and sensory processing abilities in these children.The planned study aims to address this gap by focusing on the 10- to 18-month period, evaluating motor development and sensory processing skills in infants with a history of sepsis during the early walking stage. This unique approach may provide valuable insights into the early diagnosis and intervention processes for developmental problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '10 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Late-onset sepsis is defined as sepsis that occurs after 72 hours of postnatal life and meets criteria for infectious symptoms and the presence of acute-phase reactants and/or leukopenia with positive blood cultures. The planned study aims to address the lack of evaluation of motor development and sensory processing skills in toddlers with a history of sepsis by focusing on the 10-18 month period. This unique approach may shed light on the early diagnosis and intervention processes of developmental problems.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term infants with a history of late-onset sepsis\n* Post-term infants between 10-18 months\n\nExclusion Criteria:\n\n* History of early neonatal sepsis,\n* Preterm infants,\n* Those with congenital infection or proven genetic alterations,\n* Infants diagnosed with metabolic, neurological and genetic diseases,\n* Children whose parents do not volunteer for the study'}, 'identificationModule': {'nctId': 'NCT06884969', 'briefTitle': 'Late-onset Sepsis and Development', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'Investigation of Motor Development and Sensory Processing Skills in Infants With a History of Late-onset Sepsis', 'orgStudyIdInfo': {'id': 'late-onset sepsis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Late-onset sepsis', 'description': 'Neonatal sepsis is a common condition that triggers both pro- and anti-inflammatory responses in the organism, affects various tissues, and alters enzymatic activities. Immaturity of the immune system, the use of central catheters during parenteral nutrition, and delayed enteral feeding with breast milk are known risk factors for late-onset sepsis in neonates. Late-onset sepsis is defined as sepsis that occurs after the first 72 hours of postnatal life and is characterized by the presence of infectious symptoms (such as fever, irritability, lethargy, apnea, growth retardation, feeding refusal, tachycardia, or tachypnea), acute-phase reactants (elevated interleukin-6 or C-reactive protein), and/or a positive blood culture accompanied by leukopenia.\n\nThe planned study will include toddlers with a history of late-onset sepsis, focusing on the 10-18 month period.', 'interventionNames': ['Behavioral: Test of Sensory Function in Infants', 'Behavioral: Peabody Motor Development Scale-2']}, {'label': 'Healthy infants', 'description': 'A control group consisting of healthy babies, born at term and between 10-18 months of age, with no history of sepsis will be created.', 'interventionNames': ['Behavioral: Test of Sensory Function in Infants', 'Behavioral: Peabody Motor Development Scale-2']}], 'interventions': [{'name': 'Test of Sensory Function in Infants', 'type': 'BEHAVIORAL', 'description': 'It was planned to use the Test of Sensory Function in Infants to evaluate the sensory development of infants. Test of sensory function in infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months.', 'armGroupLabels': ['Healthy infants', 'Late-onset sepsis']}, {'name': 'Peabody Motor Development Scale-2', 'type': 'BEHAVIORAL', 'description': 'Peabody Motor Development Scale-2 was planned to be used to assess motor development. Peabody Motor Development Scale-2 was designed to determine developmental delays in children between 0-72 months.', 'armGroupLabels': ['Healthy infants', 'Late-onset sepsis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niğde', 'country': 'Turkey (Türkiye)', 'facility': 'Nigde Omer Halisdemir University', 'geoPoint': {'lat': 37.96583, 'lon': 34.67935}}], 'overallOfficials': [{'name': 'Rabia ZORLULAR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nigde Omer Halisdemir University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nigde Omer Halisdemir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rabia ZORLULAR', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}