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Predictors of Sepsis in Ex-Preterm Infants

Predictors of Sepsis in Ex-Preterm Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03433846
Enrollment
40
Registered
2018-02-15
Start date
2019-04-18
Completion date
2022-05-01
Last updated
2022-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, Sepsis

Keywords

Sepsis, Prematurity

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.

Interventions

None listed

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 2 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term.Up to 1 yearThe 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.

Secondary

MeasureTime frameDescription
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 yearThe investigators will measure nutritional status. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026