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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
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.
Golisano Children's Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Test of Infant Motor Performance (TIMP)
Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay
Time frame: At approximately 36 weeks' corrected gestational age
Length of stay
Number of days in Neonatal Intensive Care Unit (NICU)
Time frame: At NICU discharge, assessed up to 1 year
Growth parameters - weight
weight z-score
Time frame: at 36 weeks' corrected gestational age and discharge
Growth parameters - length
length z-score
Time frame: at 36 weeks' corrected gestational age and discharge
Growth parameters - head circumference
head circumference z-score
Time frame: at 36 weeks' corrected gestational age and discharge
Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge
Number of neonates requiring NG, OG, or gastrostomy feeds at discharge from NICU
Time frame: at NICU discharge, assessed up to 1 year
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