Osteopathic Manipulative Medicine to Reduce Developmental Delays

Not Applicable

Completed

• Conditions: Extreme Prematurity; Neurodevelopmental Abnormality
• Interventions: Other: Osteopathic Manipulative Medicine

• Registration Number: NCT04652063
• Lead Sponsor: University of Rochester

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).

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 Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2021-01-05
• Primary Completion: 2022-12-01
• Study Completion: 2023-07-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMM	Osteopathic Manipulative Medicine	Neonates randomized to receive osteopathic manipulation

Primary Outcome Measures

Name	Time	Method
Test of Infant Motor Performance (TIMP)	At approximately 36 weeks' corrected gestational age	Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay

Secondary Outcome Measures

Name	Time	Method
Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge	at NICU discharge, assessed up to 1 year	Number of neonates requiring NG, OG, or gastrostomy feeds at discharge from NICU
Length of stay	At NICU discharge, assessed up to 1 year	Number of days in Neonatal Intensive Care Unit (NICU)
Growth parameters - weight	at 36 weeks' corrected gestational age and discharge	weight z-score
Growth parameters - length	at 36 weeks' corrected gestational age and discharge	length z-score
Growth parameters - head circumference	at 36 weeks' corrected gestational age and discharge	head circumference z-score

Trial Locations

Locations (2)

Golisano Children's Hospital; 🇺🇸 Rochester, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States