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Osteopathic Manipulative Medicine to Reduce Developmental Delays

NCT04652063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Ronnie Guillet, MD, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2022-12-01
Completion
2023-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652063 on ClinicalTrials.gov