Osteopathic Manipulative Medicine to Reduce Developmental Delays

Extreme Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652063
• Other study ID #: Study00005304
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 14 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Extreme Prematurity
• Neurodevelopmental Abnormality
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Golisano Children's Hospital	Rochester	New York
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of stay	Number of days in Neonatal Intensive Care Unit (NICU)	At NICU discharge, assessed up to 1 year
Secondary	Growth parameters - weight	weight z-score	at 36 weeks' corrected gestational age and discharge
Secondary	Growth parameters - length	length z-score	at 36 weeks' corrected gestational age and discharge
Secondary	Growth parameters - head circumference	head circumference z-score	at 36 weeks' corrected gestational age and discharge
Secondary	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