Predictors of Sepsis in Ex-Preterm Infants

NCT ID: NCT03433846

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2022-05-01

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.

Detailed Description

Preterm infants have increased numbers of viral infections in childhood. They are also more likely to die from infection during the neonatal and infant periods than infants born at term. While studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. There have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. Given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy.

The goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. Additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.

Conditions

Sepsis; Premature Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Infants born less than 37 weeks gestational age

• Infants born greater than 37 weeks gestational age

Exclusion Criteria

• Infants born greater than 37 weeks gestational age

• Infants born less than 37 weeks gestational age

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amy O'Connell

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy O'Connell, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00023454

Identifier Type: -

Identifier Source: org_study_id