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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMM | Experimental | Neonates randomized to receive osteopathic manipulation |
|
| Control | No Intervention | Neonates randomized to receive standard care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic Manipulative Medicine | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Guillet, MD, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golisano Children's Hospital | Rochester | New York | 14642 | United States | ||
| University of Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24904746 | Background | Cerritelli F, Martelli M, Renzetti C, Pizzolorusso G, Cozzolino V, Barlafante G. Introducing an osteopathic approach into neonatology ward: the NE-O model. Chiropr Man Therap. 2014 May 9;22:18. doi: 10.1186/2045-709X-22-18. eCollection 2014. | |
| 23322391 | Background | Wang L, He JL, Zhang XH. The efficacy of massage on preterm infants: a meta-analysis. Am J Perinatol. 2013 Oct;30(9):731-8. doi: 10.1055/s-0032-1332801. Epub 2013 Jan 15. |
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No plans to share HPI and data for individual participants at this time.
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Randomization 1:1 to control and intervention group
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The individual performing the developmental assessment will be unaware of study arm assignment
|
| 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 |
| Rochester |
| New York |
| 14642 |
| United States |
| 25974071 | Background | Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015. |
| 18300928 | Background | Campbell SK, Swanlund A, Smith E, Liao PJ, Zawacki L. Validity of the TIMPSI for estimating concurrent performance on the test of infant motor performance. Pediatr Phys Ther. 2008 Spring;20(1):3-10. doi: 10.1097/PEP.0b013e31815f66a6. |