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Is There a Microbiome Associated With Poor Growth in Preterm Infants?

Is There a Microbiome Associated With Poor Growth in Preterm Infants?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03761498
Enrollment
118
Registered
2018-12-03
Start date
2019-07-15
Completion date
2025-12-30
Last updated
2025-04-01

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

Conditions

Growth Disorders, Growth Failure, Prematurity

Brief summary

This study evaluates the relationship between growth and stool microbiota in premature infants.

Detailed description

Preterm infants often require increased caloric intake to maintain appropriate growth while in the neonatal intensive care unit (NICU). While some infants will have a clear source of need for greater calories, it is often not obvious why others require increased available calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut microbiota may play a role in infant and childhood growth. We hypothesize that differences in the microbial pattern in preterm infants is related to poor growth and need for increased caloric intake. This may ultimately represent a therapeutic target to improve the growth of preterm infants in the NICU. This study aims to describe the differences in microbiome which may vary with growth pattern.

Interventions

OTHERCaloric Requirement

Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.

Exclusion criteria

Infants \>27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.

Design outcomes

Primary

MeasureTime frameDescription
quantitative rT-PCR of stool microbiome8-10 weeks depending on length of stay in NICUalpha diversity of bacterial groups in normal growth vs. poor growth

Countries

United States

Outcome results

None listed

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