Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extreme Prematurity
- Sponsor
- University of Rochester
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Test of Infant Motor Performance (TIMP)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Ronnie Guillet
Professor of Pediatrics (Neonatology)
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •23 0/7- 33 6/7 weeks' gestational age (GA) at birth, ≥28 0/7 weeks' GA at time of consent
- •stable enough to tolerate gentle manipulation
Exclusion Criteria
- •\> 33 6/7 weeks' GA at birth
- •known congenital and genetic abnormalities affecting neurodevelopment
- •known conditions requiring surgical intervention
- •severe intracranial hemorrhage or other severe neurologic complications
- •parents unable to read and understand English
Outcomes
Primary Outcomes
Test of Infant Motor Performance (TIMP)
Time Frame: At approximately 36 weeks' corrected gestational age
Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay
Secondary Outcomes
- Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge(at NICU discharge, assessed up to 1 year)
- Length of stay(At NICU discharge, assessed up to 1 year)
- Growth parameters - weight(at 36 weeks' corrected gestational age and discharge)
- Growth parameters - length(at 36 weeks' corrected gestational age and discharge)
- Growth parameters - head circumference(at 36 weeks' corrected gestational age and discharge)