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NCT02000895 · ClinicalTrials.gov registry record
BLOOM: Biological Legacy of Origin in Mother-Infant Dyads
A clinical trial of Cardiovascular Diseases and Chronic Kidney Diseases, sponsored by University of Miami.
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT02000895: Recruiting study of Cardiovascular Diseases and Chronic Kidney Diseases, sponsored by University of Miami.
NCT02000895 is a study of Cardiovascular Diseases and Chronic Kidney Diseases that is actively recruiting participants, run by University of Miami. The registered enrollment target is 300 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000895, a study of Cardiovascular Diseases and Chronic Kidney Diseases, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
TKV will be measured by 2-D and 3-D renal ultrasound
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 |
What NCT02000895 shows while recruiting
NCT02000895 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 0 interventions.
NCT02000895 reports a single indexed study location in Florida.
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.
Who is sponsoring clinical trial NCT02000895?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02000895's enrollment target sits among peer trials
300 122nd of 300 higher than 175 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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