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OpenTrials
Completed

NCT Number: NCT06163586

Massage Therapy in Premature Neonates

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.

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Key information

Conditions

Neonatal Prematurity Female Urogenital Diseases and Pregnancy Complications Massage Therapy Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Neonatal Touch and Massage Therapy

Other

Structured touch and massage therapy performed by certified providers.

Primary outcomes

  1. 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

Secondary outcomes

  1. Weight gain

    Time frame: Through study intervention, an average of 4 weeks

    Assessment of daily weight in grams

  2. Linear growth

    Time frame: Through study intervention, an average of 4 weeks

    Assessment of weekly length in centimeters

  3. Head growth

    Time frame: Through study intervention, an average of 4 weeks

    Assessment of weekly head circumference in centimeters

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Feb 10, 2026

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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