Extreme Prematurity, Neurodevelopmental Abnormality
Conditions
Keywords
osteopathic manipulative medicine (OMM), test of infant motor performance (TIMP), neurodevelopmental outcomes
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.
Interventions
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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The individual performing the developmental assessment will be unaware of study arm assignment
Intervention model description
Randomization 1:1 to control and intervention group
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test of Infant Motor Performance (TIMP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | At NICU discharge, assessed up to 1 year | Number of days in Neonatal Intensive Care Unit (NICU) |
| Growth parameters - weight | at 36 weeks' corrected gestational age and discharge | weight z-score |
| Growth parameters - length | at 36 weeks' corrected gestational age and discharge | length z-score |
| Growth parameters - head circumference | at 36 weeks' corrected gestational age and discharge | head circumference z-score |
| Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge | at NICU discharge, assessed up to 1 year | Number of neonates requiring NG, OG, or gastrostomy feeds at discharge from NICU |
Countries
United States
Outcome results
None listed