Clinical trial NCT04652063: Osteopathic Manipulative Medicine to Reduce Developmental Delays
Official title: Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extreme Prematurity
Neurodevelopmental Abnormality
Keywords: osteopathic manipulative medicine (OMM)
test of infant motor performance (TIMP)
neurodevelopmental outcomes
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 to control and intervention group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test of Infant Motor Performance (TIMP)
timeFrame: At approximately 36 weeks' corrected gestational age
Secondary outcomes:
measure: Length of stay
timeFrame: At NICU discharge, assessed up to 1 year
measure: Growth parameters - weight
timeFrame: at 36 weeks' corrected gestational age and discharge
measure: Growth parameters - length
timeFrame: at 36 weeks' corrected gestational age and discharge
measure: Growth parameters - head circumference
timeFrame: at 36 weeks' corrected gestational age and discharge
measure: Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge
timeFrame: at NICU discharge, assessed up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Golisano Children's Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ronnie Guillet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.