Predictors of Sepsis in Ex-Preterm Infants

NCT03433846 | Completed

• 1 other identifier: IRB-P00023454
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to:

• Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age.
• Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.

Conditions

Sepsis; Premature Birth

Keywords

Sepsis; Prematurity

Outcome Measures

Primary Outcomes (1)

• The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.

  The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.

  Up to 1 year

Secondary Outcomes (1)

• Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization.

  Up to 1 year

Study Arms (2)

Preterm Infants

Blood samples will be obtained from preterm and former preterm infants at birth and then monthly until hospital discharge. The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen. If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.

Term Infants

Blood samples will be obtained from term control infants admitted to the NICU monthly until hospital discharge. The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen. If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.

Eligibility Criteria

• Age: 0 Days - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Both term and preterm infants will be included in the study.

You may qualify if:

• Infants born less than 37 weeks gestational age

You may not qualify if:

• Infants born greater than 37 weeks gestational age
• Infants born greater than 37 weeks gestational age
• Infants born less than 37 weeks gestational age

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will have up to 0.5 ml of blood collected as a sample within the first 1-2 weeks after the subject is enrolled. After that any discard blood samples which have been obtained as part of clinically requested blood draws will be obtained from the Core Laboratory at the institution. If there are no discard samples available an additional 0.5mL blood sample and a stool sample will be collected on a monthly basis until the subject is discharged from the hospital or up to a maximum of 6 months. If the investigators learn information that might be important for the subject's family the investigators may be able to have these results confirmed by a CLIA-certified clinical laboratory that is allowed to provide results.

MeSH Terms

Conditions

Sepsis; Premature Birth

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amy O'Connell, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 15, 2018
• Study Start: April 18, 2019
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)