Clinical trial NCT03433846: Predictors of Sepsis in Ex-Preterm Infants
Official title: Predictors of Sepsis in Ex-Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Premature Birth
Keywords: Sepsis
Prematurity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both term and preterm infants will be included in the study.

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.

Eligibility criteria: Inclusion Criteria Ex-Preterm Infant Group:

* Infants born less than 37 weeks gestational age

Exclusion Criteria for Ex-Preterm Infant Group:

* Infants born greater than 37 weeks gestational age

Inclusion Criteria for Term Infant Group:

* Infants born greater than 37 weeks gestational age

Exclusion Criteria for Term Infant Group:

* Infants born less than 37 weeks gestational age

Primary outcomes:
measure: The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Amy O'Connell, MD
role: PRINCIPAL_INVESTIGATOR
References: