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临床试验/NCT06884969
NCT06884969已完成不适用

Investigation of Motor Development and Sensory Processing Skills in Infants With a History of Late-onset Sepsis

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年3月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Peabody Developmental Motor Scales | Second Edition (PDMS-2)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Term infants with a history of late-onset sepsis
  • Post-term infants between 10-18 months

排除标准

  • History of early neonatal sepsis,
  • Preterm infants,
  • Those with congenital infection or proven genetic alterations,
  • Infants diagnosed with metabolic, neurological and genetic diseases,
  • Children whose parents do not volunteer for the study

结局指标

主要结局

Peabody Developmental Motor Scales | Second Edition (PDMS-2)

时间窗: 10-18 months

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.

Test of Sensory Functions in Infants

时间窗: 10-18 months

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.

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabia ZORLULAR

principal investigator

Nigde Omer Halisdemir University

研究点 (1)

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