Detecting kidney disease early in preterm infants
Biological Legacy of Origin in Mother-Infant Dyads
This study is trying to find early signs of kidney problems in preterm infants to help prevent serious health issues later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | N/A to 10 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT02000895 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the natural history of kidney function and size in preterm infants during their first two years of life. It focuses on infants born preterm and of low birth weight, who are at increased risk for developing cardiovascular and renal diseases later in life. The study will utilize standard serum and urine markers along with non-invasive ultrasound technology to identify early markers of kidney injury. The ultimate goal is to enable early diagnosis and potential interventions to prevent the progression of kidney disease and hypertension in these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are stable preterm infants born at less than 37 weeks' gestational age.
Not a fit: Patients who are extremely preterm (less than 24 weeks gestational age) or have significant anomalies of the genital-urinary or gastrointestinal tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early interventions that prevent the development of hypertension and chronic kidney disease in preterm infants.
How similar studies have performed: Other studies have shown promising results in identifying early markers of kidney injury in preterm infants, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami/ Holtz Children's Hospital — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Marissa J DeFreitas, MD — University of Miami
- Study coordinator: Marissa J DeFreitas, MD
- Email: MDefreitas@med.miami.edu
- Phone: 305-585-6726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.