NCT04652063

Osteopathic Manipulative Medicine to Reduce Developmental Delays

Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 1 Day – 14 Weeks
• Healthy volunteers: Accepted

Summary

This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).

Detailed description

Hypothesis: High risk preterm infants born \<34 weeks of gestation who receive OMM, compared to the standard supportive care, will have improved neuromotor development scores on the TIMP. Specific Aims and Objectives: Primary aim: To determine the difference in TIMP scores between infants who receive OMM and those who receive only standard neonatal intensive care unit (NICU) care. Secondary aims: * To compare length of stay between infants who receive OMM and those who receive only standard NICU care. * To compare growth parameters including weight, length, and head circumference, (both means and Z scores) prior to discharge between infants who receive OMM and those who receive only standard NICU care. * To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive OMM and those who receive only standard NICU care.

Conditions

• Extreme Prematurity
• Neurodevelopmental Abnormality

Interventions

Type	Name	Description
OTHER	Osteopathic Manipulative Medicine	Osteopathic evaluation and treatment (gentle touch according to published protocols) will take about 15 - 20 minutes, and will be performed every 7 - 10 days during the infant's NICU stay once they reach at minimum of at least 28 weeks corrected gestational age and until they reach 36 weeks corrected gestational age.

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-12-01
• Completion: 2023-07-30
• First posted: 2020-12-03
• Last updated: 2023-08-14

Locations

2 sites across 1 country: United States