BLOOM: Biological Legacy of Origin in Mother-Infant Dyads

NCT02000895 | Recruiting

• 4 other identifiers: 201009865KL2TR002737-0466787R701170
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiovascular Diseases; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Change in total kidney volume (TKV) from birth to 10 years

  TKV will be measured by 2-D and 3-D renal ultrasound

  Birth, 1 year, 2 years, 6 years, 10 years

Secondary Outcomes (4)

• Development of Hypertension

  1 year, 2 years, 6 years, 10 years

• Vascular density

  1 year, 2 years, 6 years, 10 years

• Vascular stiffness

  1 year, 2 years, 6 years, 10 years

• Change in estimated glomerular filtration rate (eGFR) from birth to 2 years

  Birth, 1 year, 2 years, 6 years, 10 years

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants from 24 to 37 weeks' gestation enrolled at birth to be studied for kidney size and function. Term infants \>37 weeks' gestation who are stable without complications to serve as controls. Follow-up of preterm and term birth cohort(s) at 6-10 years of age.

You may qualify if:

• Stable preterm infants \<37 weeks' gestational age; Stable term infants \>37 weeks' gestational age

You may not qualify if:

• \<24 weeks gestational age; \<600 grams Any anomalies of the genital-urinary or gastrointestinal tract

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of Miami: lead
• The Gerber Foundation: collaborator
• Micah Batchelor Foundation: collaborator

Study Sites (1)

University of Miami/ Holtz Children's Hospital

Miami, Florida, 33136, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 24607244 RESULT

• 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.

  PMID: 26862052 RESULT

• 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.

  PMID: 28260559 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Cord Blood Umbilical cords

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marissa J DeFreitas, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa J DeFreitas, MD

CONTACT

305-585-6726; MDefreitas@med.miami.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 4, 2013
• Study Start: July 23, 2011
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)