A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
Metabolic Bone Disease, Osteopenia, Neonatal Rickets
About this trial
This is an interventional diagnostic trial for Metabolic Bone Disease focused on measuring Bone Diseases, bone health, Fracture, infancy, Low Birth Weight Infant, mineralization, Neonatal, Pediatrics, Premature, ultrasound, Rickets
Eligibility Criteria
Inclusion Criteria:
- Full term newborns, approximately equal number of male and female newborn, age <28 days.
- Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth <37 weeks or birth weight <1500 grams.
Exclusion Criteria:
- Infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past.
- Infants with major congenital anomalies that may affect bone health or structure.
- For full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (<10th percentile for weight) at birth.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Other
premature infants and full term infants
The study visits will be at ≥3 time points at ages: within the first 28 days after birth, 2 months, 3 months, and, if still hospitalized, at 4 months and at 6 months. The ultrasound machine to the nursery or neonatal intensive care unit at a scheduled time. The appropriate ultrasound probe will be placed on the infant's tibia and a miniature hydrophone near the probe. A series of ultrasound measurements will be obtained and the ultrasound data will be saved for offline processing. The Investigators will repeat the measurement in 3 locations of the infant's tibia. Each ultrasound measurement takes a few seconds. The complete ultrasound study will take about 15 minutes at each visit. All procedures will be conducted in the nursery or neonatal intensive care unit to ensure infant safety. The ultrasound measurement for full-term infants can be done in ultrasound lab.