BONE SOS Study

Premature babies often have challenges with bone development since a significant amount of bone mineralization occurs during the last trimester of pregnancy. Current methods to assess bone health in these infants have considerable limitations– blood tests do not correlate well with actual bone status, and X-rays only show changes after substantial mineral loss has occurred. Advanced ultrasound technology that measures the speed of sound (SOS) through bone may provide a safe, non-invasive way to monitor bone health in premature babies and help prevent metabolic bone disease of prematurity.

This study aims to validate a bedside tool that uses ultrasound technology to assess bone health in premature infants. The measurements are painless, non-invasive and similar to a regular ultrasound. By tracking bone development from birth through the first two years of life, we hope to better understand how bones develop in premature infants and identify early signs of potential bone problems. This could help doctors provide better care and prevent bone-related complications in premature babies.

Babies will receive their usual medical care, and we will perform regular ultrasound measurements of their leg bone (tibia) every two weeks during their hospital stay. We will continue to monitor their bone health at their regular follow-up visits at 1 and 2 years of age (optional). The study will also track growth, development, and how different treatments might affect bone health.

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Purpose & Aim

To validate speed of sound (SOS) technology as a reliable tool for monitoring bone health in premature infants and understand how various factors affect bone development.

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Study Population

• Extremely preterm infants (< 28 weeks gestation or < 1000 grams at birth)

• Term infants (≥ 37 weeks gestation) as control group

• Admitted to Children’s Memorial Hermann Hospital

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Intervention

Non-invasive ultrasound measurements of the tibia using the Sunlight MiniOmni device

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Outcomes

• Bone health measurements (SOS values)
• Growth parameters
• Correlation with traditional bone health markers as routine care
• Impact of medications and treatments on bone health
• Neurodevelopmental assessment at 2 years of age for former preterm infants < 28 weeks gestation and following at UT Health High risk clinic (optional)

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Recruitment Target

• 120 preterm infants
• 90 term infants

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Duration of Study

Open-ended enrollment with 2-year follow-up for each participant (optional)

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Study Principal Investigators