Osteopathic Manipulative Medicine to Reduce Developmental Delays

NCT04652063 | Completed DMC

• 1 other identifier: Study00005304
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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).

Conditions

Extreme Prematurity; Neurodevelopmental Abnormality

Keywords

osteopathic manipulative medicine (OMM); test of infant motor performance (TIMP); neurodevelopmental outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of stay

  At NICU discharge, assessed up to 1 year

• Growth parameters - weight

  at 36 weeks' corrected gestational age and discharge

• Growth parameters - length

  at 36 weeks' corrected gestational age and discharge

• Growth parameters - head circumference

  at 36 weeks' corrected gestational age and discharge

• Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge

  at NICU discharge, assessed up to 1 year

Study Arms (2)

OMM

EXPERIMENTAL

Neonates randomized to receive osteopathic manipulation

Other: Osteopathic Manipulative Medicine

Control

NO INTERVENTION

Neonates randomized to receive standard care only

Interventions

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.

OMM

Eligibility Criteria

• Age: 1 Day - 14 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• /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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

Golisano Children's Hospital

Rochester, New York, 14642, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (4)

• 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.

  PMID: 24904746 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.

  PMID: 23322391 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.

  PMID: 25974071 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.

  PMID: 18300928 BACKGROUND

Study Officials

• Ronnie Guillet, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The individual performing the developmental assessment will be unaware of study arm assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics (Neonatology)

Model Details: Randomization 1:1 to control and intervention group

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: January 5, 2021
• Primary Completion: December 1, 2022
• Study Completion: July 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)