Late-onset Sepsis and Development

Nigde Omer Halisdemir University

Status: Completed

Conditions: Sensory Integration Dysfunction; Sepsis Newborn; Motor Development

Treatments: Behavioral: Peabody Motor Development Scale-2; Behavioral: Test of Sensory Function in Infants

Study type: Observational

Funder types: Other

Identifiers

NCT06884969

late-onset sepsis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 10 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

57 participants in 2 patient groups

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. The planned study will include toddlers with a history of late-onset sepsis, focusing on the 10-18 month period.

Treatment:

Behavioral: Test of Sensory Function in Infants

Behavioral: Peabody Motor Development Scale-2

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.

Treatment:

Behavioral: Test of Sensory Function in Infants

Behavioral: Peabody Motor Development Scale-2