SepsisNCT04103268
Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis
An observational study of Sepsis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Sepsis
- What is being tested?
- sepsis
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2020to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 17 years
- All sexes
- Child
Study population: We will enroll pediatric patients with sepsis in an ICU at Boston Children's Hospital and patients without sepsis presenting for an elective surgical procedure at Boston Children's Hospital.
Inclusion criteria Patients will be eligible for enrollment as septic patients if they
- Are < 18 years old
- Meet the definition of sepsis described in the study design section above. Patients will be eligible for enrollment as control patients if they
- Are < 18 years old
- Are scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure.
Exclusion criteria Patients will be ineligible for enrollment in either control or sepsis group if any of the followings is present or anticipated
- Congenital cardiac disease
- On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Koichi Yuki, MD, 617-355-6225, koichi.yuki@childrens.harvard.edu
About this study
In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.
- Conditions
- Sepsis
- Being tested
- sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sepsisOther
patients in the ICU with infection called sepsis
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Not described Receives: Other: sepsis | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil populations
compare gene expression in neutrophils between sepsis patients and non-sepsis patients in pediatric population to report unregulated and down regulated genes
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start4 Aug 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Yuki, Boston Children's Hospital
- Investigators
- Koichi Yuki, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103268
- Sponsor's protocol ID
- IRB-P00031930
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alhamdan F, Sin YC, Malm E, Van Pelt H, Kim S, Higgins L, Chen Y, Yuki K. Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers. FASEB Bioadv. 2026 Mar 9;8(3):e70098. doi: 10.1096/fba.2026-00006. eCollection 2026 Mar.
PubMed 41815387Alhamdan F, Gianoli S, Yuki K, Koutsogiannaki S. Single-cell analysis of B cell dysregulation in pediatric sepsis stratified by disease severity. Sci Rep. 2025 Dec 31;16(1):3987. doi: 10.1038/s41598-025-34126-9.
PubMed 41476192
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04103268
- Acronym / sponsor ID
- IRB-P00031930
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Sep 2019 (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.
In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: sepsis |
| Control | – | – |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- We will enroll pediatric patients with sepsis in an ICU at Boston Children's Hospital and patients without sepsis presenting for an elective surgical procedure at Boston Children's Hospital.
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 |
|---|---|---|
| sepsispatients in the ICU with infection called sepsis | Other | Sepsis |
Primary outcome
neutrophil populations
Time frame: up to 1 month
compare gene expression in neutrophils between sepsis patients and non-sepsis patients in pediatric population to report unregulated and down regulated genes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 41815387Alhamdan F, Sin YC, Malm E, Van Pelt H, Kim S, Higgins L, Chen Y, Yuki K. Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers. FASEB Bioadv. 2026 Mar 9;8(3):e70098. doi: 10.1096/fba.2026-00006. eCollection 2026 Mar.
- Derived from this study: PubMed 41476192Alhamdan F, Gianoli S, Yuki K, Koutsogiannaki S. Single-cell analysis of B cell dysregulation in pediatric sepsis stratified by disease severity. Sci Rep. 2025 Dec 31;16(1):3987. doi: 10.1038/s41598-025-34126-9.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Koichi Yuki, MD principal investigator
Boston Children's Hospital
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, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koichi Yuki, MD (617-355-6225, koichi.yuki@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutrophil populations (time frame: up to 1 month). 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 NCT04103268, which also lists 2 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 7 Jan 2026.