Massage Therapy in Premature Neonates

February 6, 2026 updated by: Johana Diaz, University of Maryland, Baltimore

Effects of Neonatal Therapeutic Touch and Massage in Very Preterm and Extremely Preterm Neonates: A Randomized Controlled Trial

The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies.

The main questions it aims to answer are:

  • Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
  • Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes.

Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the effects of Neonatal Touch and Massage Therapy on premature infants in the NICU. Babies enrolled in this study will be randomly assigned to receive Neonatal Touch and Massage or standard NICU care. Babies in the therapy group will be given Neonatal Touch or Massage therapy by certified providers 3 days per week for 5 to 15 minutes. Therapy will be done for a minimum of 4 weeks. The investigators will assess pain and stress responses before and after treatment. The investigators will also review participant's medical records to collect information about weight gain, length of hospitalization, and general health status. After a participant is discharged home, information will be collected about participant's developmental assessments at regularly scheduled NICU follow-up clinic appointments. There are no significant risks with this therapy. Potential benefits of therapy include increased weight gain, shorter hospitalization, decreased pain and stress, and improved developmental outcomes. Information gained from this study could also help future babies.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants born or admitted to University of Maryland NICU in the first 14 days of life
  • Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth
  • Deemed medically stable by the medical care team

Exclusion Criteria:

  • Life limiting conditions, including genetic syndromes
  • Cyanotic heart disease
  • Requiring major surgery or critically ill at time of intervention
  • Osteopenia of prematurity with an existing fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This group will receive structured neonatal touch or massage therapy from a certified NICU provider. Therapy will given 3 days a week for 5 to 15 minutes for a minimum of 4 weeks. We will also be collecting data to assess pain and stress responses during the period immediately before, during, and shortly after the therapy. This includes assessment of crying/irritability, behavior state, facial expression, extremities tone, and vital signs (heart rate, breathing rate, and oxygen levels).
Other: Neonatal Touch and Massage Therapy
Structured touch and massage therapy performed by certified providers.
No Intervention: Control
This group will receive standard NICU care, no different than if they were not enrolled in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Day of birth to discharge home, up to 6 months
Total length of hospitalization, from NICU admission to discharge home in days
Day of birth to discharge home, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight gain
Time Frame: Through study intervention, an average of 4 weeks
Assessment of daily weight in grams
Through study intervention, an average of 4 weeks
Linear growth
Time Frame: Through study intervention, an average of 4 weeks
Assessment of weekly length in centimeters
Through study intervention, an average of 4 weeks
Head growth
Time Frame: Through study intervention, an average of 4 weeks
Assessment of weekly head circumference in centimeters
Through study intervention, an average of 4 weeks
Neurodevelopmental Outcomes
Time Frame: Within in 1 week of NICU discharge or transfer until up to 3 years of age
Prior to NICU discharge or transfer each subject will undergo a Neonatal Neurobehavioral Scale (NNNS-II) assessment by a certified examiner. This is a comprehensive evaluation of neurological integrity and behavioral function including reflexes, motor development, and active and passive tone. NNNS profiles have been demonstrated to be predictive of short term cognitive, motor, and behavioral outcomes after NICU discharge. Standardized neurodevelopmental assessments will also be completed at regularly scheduled NICU follow-up clinic visits
Within in 1 week of NICU discharge or transfer until up to 3 years of age
Pain scores
Time Frame: 1 hour before intervention and up to 3 hours post-intervention
Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, a validated assessment tool using a combination of physiologic and behavioral indices, will documented before and after therapy to evaluate pain and stress responses. The scale has a minimum value of -10 and maximum value of +10, with a higher score indicating more pain.
1 hour before intervention and up to 3 hours post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Johana Diaz, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00098293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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