An observational study in Growth Disorders, Growth Failure and Prematurity, sponsored by University of Texas Southwestern Medical Center. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by University of Texas Southwestern Medical Center · Observational
This study evaluates the relationship between growth and stool microbiota in premature infants.
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.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
This study's enrollment of 118 is below the median of 231 across 78 observational studies indexed under Growth Disorders.
Browse Growth Disorders studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Preterm infants born at less than 28 weeks gestation will be eligible from birth until discharge. Infants with major congenital anomalies which alter growth patterns will be excluded.
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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.
Require less than or equal to 110 kcal/kg/day to maintain growth curve
Require more than 110 kcal/kg/day to maintain growth curve
Other: Caloric Requirement
Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.
quantitative rT-PCR of stool microbiome
alpha diversity of bacterial groups in normal growth vs. poor growth
Time frame: 8-10 weeks depending on length of stay in NICU
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for Dec 2025, 77 months after the start.
Of 42 observational studies under Growth Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's planned 77 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center →