Late-onset Sepsis and Development

NCT06884969 | Completed

• 1 other identifier: late-onset sepsis
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Newborn; Motor Development; Sensory Integration Dysfunction

Keywords

sepsis; motor development; sensory processing skills; infant

Outcome Measures

Primary Outcomes (2)

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

  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.

  10-18 months

• Test of Sensory Functions in Infants

  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.

  10-18 months

Study Arms (2)

Late-onset sepsis

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.

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

Healthy infants

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.

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

Interventions

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.

Healthy infants; Late-onset sepsis

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.

Healthy infants; Late-onset sepsis

Eligibility Criteria

• Age: 10 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

Related Publications (5)

• Folio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.

  BACKGROUND

• 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.

  BACKGROUND

• 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: 15547163 BACKGROUND

• 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: 22371459 BACKGROUND

• 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.

  PMID: 41175143 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabia ZORLULAR

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: March 19, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)