Growth DisordersNCT03761498
Is There a Microbiome Associated With Poor Growth in Preterm Infants?
An observational study of Growth Disorders and Growth Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study evaluates the relationship between growth and stool microbiota in premature infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Disorders, Growth Failure, Prematurity
- What is being tested?
- Caloric Requirement
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.
Who cannot join
- Infants >27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Hopsital and Health System
Dallas, Texas, 75235
About this study
This study evaluates the relationship between growth and stool microbiota in premature infants.
Read the 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.
- Conditions
- Growth Disorders, Growth Failure, Prematurity
- Being tested
- Caloric Requirement
- Medical subject headings
- Growth Disorders, Failure to Thrive, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RequirementOther
Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.
| Study group | Role | What they receive |
|---|---|---|
| Normal Growth | Require less than or equal to 110 kcal/kg/day to maintain growth curve | |
| Slow Growth | Require more than 110 kcal/kg/day to maintain growth curve Receives: Other: Caloric Requirement |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative rT-PCR of stool microbiome
alpha diversity of bacterial groups in normal growth vs. poor growth
Measured: 8-10 weeks depending on length of stay in NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start15 Jul 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Anne Stumpf, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761498
- Sponsor's protocol ID
- STU 042018-061
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2018
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Microbiome Associated With Poor Growth in Preterm Infants?
- ClinicalTrials.gov ID
- NCT03761498
- Acronym / sponsor ID
- STU 042018-061
- Conditions
- Growth Disorders, Growth Failure, Prematurity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Growth | – | –Require less than or equal to 110 kcal/kg/day to maintain growth curve |
| Slow Growth | – | Other: Caloric RequirementRequire more than 110 kcal/kg/day to maintain growth curve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU.
Key exclusion criteria (1 listed)
- Infants >27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric RequirementInfants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place. | Other | Slow Growth |
Primary outcome
quantitative rT-PCR of stool microbiome
Time frame: 8-10 weeks depending on length of stay in NICU
alpha diversity of bacterial groups in normal growth vs. poor growth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Disorders and Growth Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative rT-PCR of stool microbiome (time frame: 8-10 weeks depending on length of stay in NICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.