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NCT Number: NCT06884969

Late-onset Sepsis and Development

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.

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Key information

Conditions

Sepsis Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Motor Development Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sensory Integration Dysfunction Sepsis Systemic Inflammatory Response Syndrome

Age range

10 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test of Sensory Function in Infants

Behavioral

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.

Peabody Motor Development Scale-2

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

  2. Test of Sensory Functions in Infants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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