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NCT Number: NCT04652063

Osteopathic Manipulative Medicine to Reduce Developmental Delays

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).

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Key information

Conditions

Extreme Prematurity Neurodevelopmental Abnormality

Age range

1 day–14 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golisano Children's Hospital, Rochester, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Test of Infant Motor Performance (TIMP)

    Time frame: 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 outcomes

  1. Length of stay

    Time frame: At NICU discharge, assessed up to 1 year

    Number of days in Neonatal Intensive Care Unit (NICU)

  2. Growth parameters - weight

    Time frame: at 36 weeks' corrected gestational age and discharge

    weight z-score

  3. Growth parameters - length

    Time frame: at 36 weeks' corrected gestational age and discharge

    length z-score

  4. Growth parameters - head circumference

    Time frame: at 36 weeks' corrected gestational age and discharge

    head circumference z-score

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

    Time frame: at NICU discharge, assessed up to 1 year

    Number of neonates requiring NG, OG, or gastrostomy feeds at discharge from NICU

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 3, 2020
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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