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BLOOM: Biological Legacy of Origin in Mother-Infant Dyads
NCT02000895 · View on ClinicalTrials.gov ↗
Study Summary
Infants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in adult life. This has been related to low nephron mass due to inadequate or early termination of glomerulogenesis in utero and during the perinatal period. Risks for subsequent development of hypertension and kidney disease include proteinuria, excessive weight gain during early life with insulin resistance and supplemental high calorie feedings. The long-term goal is for early diagnosis of those infants who are at risk for future development of hypertension and kidney disease so that the investigators might intervene to potentially avert progression to adult disease. The objective of this clinical trial is to acquire data on the natural history of neonatal kidney function and size in infants born preterm during the first 2 years of life. This will be done through the use of standard serum and urine markers as well as non-invasive ultrasound technology. The central hypothesis of this clinical trial is that a subgroup of patients born preterm and of low birth weight will demonstrate early markers of kidney injury including elevated serum cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis of preliminary data from our group studying this question retrospectively in older children born prematurely who have developed overt kidney disease. The rationale for the proposed research is to develop early serum and demographic markers of pre-clinical kidney disease so that early intervention can occur. The proposed clinical trial is innovative because it will investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of gaining more knowledge regarding therapeutic interventions. In addition, the study will assess serum cystatin C as a surrogate test for glomerular filtration rate which could indicate worsening kidney function at an earlier stage than serum creatinine. The pr
Conditions Studied
Study Locations (1)
Florida
- University of Miami/ Holtz Children's Hospital — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-07-23 |
| Est. Completion | 2029-01-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02000895
The ClinicalTrials.gov registry entry for NCT02000895 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02000895 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02000895 about?
NCT02000895 is a clinical study titled "BLOOM: Biological Legacy of Origin in Mother-Infant Dyads". Infants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in adult life. This has been related to low nephron mass due to inadequate or early termination of glomerulogenesis in utero and during the perinatal period. Risks for s...
What is the current status of trial NCT02000895?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2011-07-23. Estimated completion is 2029-01-01.
What conditions does trial NCT02000895 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Chronic Kidney Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02000895?
This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02000895 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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