Clinical Trials Logo
  1. Home
  2. Prematurity
  3. NCT03761498
  4. Details
NCT03761498 Clinical Trial

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

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03761498
Other study ID # STU 042018-061
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date December 30, 2025

Study information
Verified date April 2024
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 118
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Parkland Hopsital and Health System Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary quantitative rT-PCR of stool microbiome alpha diversity of bacterial groups in normal growth vs. poor growth 8-10 weeks depending on length of stay in NICU
See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Completed NCT05322161 - Yoga in the NICU for Parents Study N/A
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT04911452 - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants N/A
Recruiting NCT02901652 - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome N/A
Completed NCT02148965 - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial N/A
Terminated NCT02032511 - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP) N/A
Completed NCT02273843 - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis Phase 1
Completed NCT01721629 - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants N/A
Terminated NCT01819532 - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks N/A
Completed NCT00951860 - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort N/A
Completed NCT01523769 - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants N/A
Completed NCT01478711 - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Completed NCT00749008 - Study of Generalized Movements for Early Prediction of Cerebral Palsy N/A
Terminated NCT00486395 - Will CPAP Reduce Length Of Respiratory Support In Premature Infants? Phase 3
Terminated NCT01208493 - Dietary Protein in the Very-low-birth-weight Infant N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03372590 - NEO Rehab for Infants at Risk of Cerebral Palsy N/A
Completed NCT00033917 - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial Phase 3