Sepsis NewbornNCT06884969
Late-onset Sepsis and Development
An observational study of Sepsis Newborn and Motor Development, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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%. Read more about this study
- Who is it for?
- Ages 10 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Sepsis Newborn, Motor Development, Sensory Integration Dysfunction
- What is being tested?
- Test of Sensory Function in Infants and Peabody Motor Development Scale-2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Term infants with a history of late-onset sepsis
- Post-term infants between 10-18 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Motor Development and Sensory Processing Skills in Infants With a History of Late-onset Sepsis
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.
Read the 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.
- Being tested
- Test of Sensory Function in Infants, Peabody Motor Development Scale-2
- Keywords
- sepsis, motor development, sensory processing skills, infant
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of Sensory Function in InfantsBehavioural
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-2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Test of Sensory Function in Infants; Behavioral: Peabody Motor Development Scale-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start19 Mar 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sepsis NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
- Investigators
- Rabia ZORLULAR, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884969
- Sponsor's protocol ID
- late-onset sepsis
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.
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.
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.
PubMed 15547163Greenhow 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.
PubMed 22371459Zorlular 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.
PubMed 41175143
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Motor Development and Sensory Processing Skills in Infants With a History of Late-onset Sepsis
- ClinicalTrials.gov ID
- NCT06884969
- Acronym / sponsor ID
- late-onset sepsis
- Keywords
- sepsis, motor development, sensory processing skills, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late-onset sepsis | – | Behavioral: Test of Sensory Function in Infants, Behavioral: Peabody Motor Development Scale-2Neonatal 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. |
| Healthy infants | – | Behavioral: Test of Sensory Function in Infants, Behavioral: Peabody Motor Development Scale-2A control group consisting of healthy babies, born at term and between 10-18 months of age, with no history of sepsis will be created. |
Who may qualify
- Ages
- 10 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Term infants with a history of late-onset sepsis
- Post-term infants between 10-18 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of Sensory Function in InfantsIt 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. | Behavioural | Healthy infants, Late-onset sepsis |
| Peabody Motor Development Scale-2Peabody 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. | Behavioural | Healthy infants, Late-onset sepsis |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publicationFolio, M.R., Peabody developmental motor scales. DLM Teaching Resources, 1983.
- Results publicationDeGangi, G.A. and S.I. Greenspan, The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics, 1989. 8(4): p. 21-33.
- Results publication: PubMed 15547163Stoll 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.
- Results publication: PubMed 22371459Greenhow 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.
- Derived from this study: PubMed 41175143Zorlular 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia ZORLULAR principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Newborn and Motor Development, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales | Second Edition (PDMS-2) (time frame: 10-18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884969, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.