Osteopathic Manipulative Medicine to Reduce Developmental Delays

University of Rochester

Status: Completed

Conditions: Extreme Prematurity; Neurodevelopmental Abnormality

Treatments: Other: Osteopathic Manipulative Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04652063

Study00005304

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 1 day to 14 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

OMM

Experimental group

Description:

Neonates randomized to receive osteopathic manipulation

Treatment:

Other: Osteopathic Manipulative Medicine

Control

No Intervention group

Description:

Neonates randomized to receive standard care only