RecruitingNCT02000895

BLOOM: Biological Legacy of Origin in Mother-Infant Dyads

Biological Legacy of Origin in Mother-Infant Dyads


Sponsor

University of Miami

Enrollment

300 participants

Start Date

Jul 23, 2011

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how a mother's health, stress levels, and behaviors during and after pregnancy affect the biological development of her baby in the first year of life, including how stress hormones, gut bacteria, and immune function develop in mother-infant pairs. **You may be eligible if...** - You are a pregnant woman in your third trimester (last three months of pregnancy) - You are carrying a single baby (not twins or more) - You plan to breastfeed or formula feed and are willing to be followed with your baby for the first year after birth - You are willing to provide saliva, blood, stool, and breast milk samples at various time points **You may NOT be eligible if...** - You have a serious medical condition that significantly affects pregnancy (such as preeclampsia or gestational diabetes) - You are carrying twins or multiple babies - You are unwilling to complete the sample collection schedule - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University of Miami/ Holtz Children's Hospital

Miami, Florida, United States

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NCT02000895


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