Osteopathic Manipulative Medicine to Reduce Developmental Delays

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extreme Prematurity, Neurodevelopmental Abnormality

Intervention / Treatment
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* Other: Osteopathic Manipulative Medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization 1:1 to control and intervention group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMM<br>Neonates randomized to receive osteopathic manipulation | Other: Osteopathic Manipulative Medicine<br>* 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.<br>|
| No Intervention: Control<br>Neonates randomized to receive standard care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At approximately 36 weeks' corrected gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days in Neonatal Intensive Care Unit (NICU) | At NICU discharge, assessed up to 1 year | 
| Growth parameters - weight | weight z-score | at 36 weeks' corrected gestational age and discharge | 
| Growth parameters - length | length z-score | at 36 weeks' corrected gestational age and discharge | 
| Growth parameters - head circumference | head circumference z-score | 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 | at NICU discharge, assessed up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathic manipulative medicine (OMM), neurodevelopmental outcomes, test of infant motor performance (TIMP)