Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06884969
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2025-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Late-onset Sepsis and Development
Sponsor:
Nigde Omer Halisdemir University
Organization:
Study Overview
Official Title:
Investigation of Motor Development and Sensory Processing Skills in Infants With a History of Late-onset Sepsis
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: