Osteopathic Manipulative Medicine to Reduce Developmental Delays
NCT ID: NCT04652063
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2021-01-05
2023-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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OMM
Neonates randomized to receive osteopathic manipulation
Osteopathic Manipulative Medicine
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.
Control
Neonates randomized to receive standard care only
No interventions assigned to this group
Interventions
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Osteopathic Manipulative Medicine
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.
Eligibility Criteria
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Inclusion Criteria
* stable enough to tolerate gentle manipulation
Exclusion Criteria
* 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
1 Day
14 Weeks
ALL
Yes
Sponsors
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University of Rochester
OTHER
Responsible Party
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Ronnie Guillet
Professor of Pediatrics (Neonatology)
Principal Investigators
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Ronnie Guillet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Golisano Children's Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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Study00005304
Identifier Type: -
Identifier Source: org_study_id
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