Osteopathic Manipulative Medicine to Reduce Developmental Delays

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

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).

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Abnormality; Extreme Prematurity
• Intervention / Treatment: Other: Osteopathic Manipulative Medicine

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela K Tyson, DO; Phone Number: 585-275-1847; Email: angela_tyson@urmc.rochester.edu
• Study Contact Backup: Name: Elizabeth R Carbonell, MPH; Phone Number: 585-273-2322; Email: elizabeth_carbonell@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14642
      • Golisano Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMM; Neonates randomized to receive osteopathic manipulation	Other: 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.
No Intervention: Control; Neonates randomized to receive standard care only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Ronnie Guillet, MD, PhD, University of Rochester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: osteopathic manipulative medicine (OMM); test of infant motor performance (TIMP); neurodevelopmental outcomes
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital Abnormalities; Premature Birth
• Other Study ID Numbers: Study00005304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share HPI and data for individual participants at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No