- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000895
Early Detection of Progressive Kidney Disease in Preterm Infants
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 proposed research is significant because it is expected to identify at-risk patients for future renal impairment and to prospectively monitor the persistence of proteinuria and its effect on kidney function in the short term.
Study Overview
Status
Conditions
Detailed Description
Objectives and Hypotheses:
Infants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in later 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 excessive weight gain during early life with insulin resistance and supplemental high calorie feedings.
Specific Aims 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 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 year 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 will demonstrate early markers of kidney injury including elevated serum cystatin C, proteinuria and hypertension. This hypothesis has been formulated on the basis of preliminary data from the 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 may occur.
Study Design. This is a single-center case-controlled prospective observational study with the rationale of evaluating parameters of renal function including proteinuria, microalbuminuria and cystatin C in preterm infants and associating this with kidney size and blood pressure during the first 10 years of life. Demographics including race, gender and growth will provide important perspectives relative to formula and/or breast feeding with/without high calorie supplements during the first year.
Part I of the Trial is enrollment from birth with collection of blood, urine and umbilical cords for histomorphometry.
Part II will be the "call-back" at 6 to 10 years of age for follow-up assessment of anthropometric and kidney growth, blood pressure and kidney function.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marissa J DeFreitas, MD
- Phone Number: 305-585-6726
- Email: mdefreitas@med.miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami/ Holtz Children's Hospital
-
Contact:
- Marissa J DeFreitas, MD
- Phone Number: 305-585-6726
- Email: mdefreitas@med.miami.edu
-
Contact:
- Carolyn L Abitbol, MD
- Phone Number: 305-585-6726
- Email: cabitbol@med.miami.edu
-
Sub-Investigator:
- Karen Young, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Stable preterm infants <37 weeks' gestational age; Stable term infants >37 weeks' gestational age
Exclusion Criteria:
<24 weeks gestational age; <600 grams Any anomalies of the genital-urinary or gastrointestinal tract
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Preterm infants
>24 weeks <37 weeks gestational age
|
Term infants
>37 weeks' gestational age
|
Follow-up at 6 Years
Children enrolled from the birth cohort(s) to be followed at 6 to 10 years of age.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total kidney volume (TKV) from birth to 10 years
Time Frame: Birth, 1 year, 2 years, 6 years, 10 years
|
TKV will be measured by 2-D and 3-D renal ultrasound
|
Birth, 1 year, 2 years, 6 years, 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of Hypertension
Time Frame: 1 year, 2 years, 6 years, 10 years
|
Blood pressure measurements by sphygmomanometer
|
1 year, 2 years, 6 years, 10 years
|
Vascular density
Time Frame: 1 year, 2 years, 6 years, 10 years
|
Capillary density/ rarefaction to be measured via capillaroscopy
|
1 year, 2 years, 6 years, 10 years
|
Vascular stiffness
Time Frame: 1 year, 2 years, 6 years, 10 years
|
Vascular stiffness measured as pulse wave velocity by tonometry
|
1 year, 2 years, 6 years, 10 years
|
Change in estimated glomerular filtration rate (eGFR) from birth to 2 years
Time Frame: Birth, 1 year, 2 years, 6 years, 10 years
|
Estimated GFR will be calculated from serum creatinine and Cystatin C
|
Birth, 1 year, 2 years, 6 years, 10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marissa J DeFreitas, MD, University of Miami
Publications and helpful links
General Publications
- Abitbol CL, Seeherunvong W, Galarza MG, Katsoufis C, Francoeur D, Defreitas M, Edwards-Richards A, Master Sankar Raj V, Chandar J, Duara S, Yasin S, Zilleruelo G. Neonatal kidney size and function in preterm infants: what is a true estimate of glomerular filtration rate? J Pediatr. 2014 May;164(5):1026-1031.e2. doi: 10.1016/j.jpeds.2014.01.044. Epub 2014 Mar 5.
- DeFreitas MJ, Seeherunvong W, Katsoufis CP, RamachandraRao S, Duara S, Yasin S, Zilleruelo G, Rodriguez MM, Abitbol CL. Longitudinal patterns of urine biomarkers in infants across gestational ages. Pediatr Nephrol. 2016 Jul;31(7):1179-88. doi: 10.1007/s00467-016-3327-3. Epub 2016 Feb 9.
- DeFreitas MJ, Mathur D, Seeherunvong W, Cano T, Katsoufis CP, Duara S, Yasin S, Zilleruelo G, Rodriguez MM, Abitbol CL. Umbilical artery histomorphometry: a link between the intrauterine environment and kidney development. J Dev Orig Health Dis. 2017 Jun;8(3):349-356. doi: 10.1017/S2040174417000113. Epub 2017 Mar 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20100986
- 66787R (Other Grant/Funding Number: Gerber Foundation)
- 701170 (Other Grant/Funding Number: Micah Batchelor Foundation)
- 5KL2TR002737-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted