Osteopathic Manipulative Medicine to Reduce Developmental Delays

Extreme Prematurity Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Congenital Abnormalities
• Extreme Prematurity
• Neurodevelopmental Abnormality
• Premature Birth

• NCT number: NCT04652063
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Completion date: July 30, 2023