Massage Therapy in Premature Neonates
- Conditions
- Neonatal PrematurityMassage Therapy
- Interventions
- Other: Neonatal Touch and Massage Therapy
- Registration Number
- NCT06163586
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Neonatal Touch and Massage Therapy 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).
- Primary Outcome Measures
Name Time Method Length of stay Day of birth to discharge home, up to 6 months Total length of hospitalization, from NICU admission to discharge home in days
- Secondary Outcome Measures
Name Time Method Linear growth Through study intervention, an average of 4 weeks Assessment of weekly length in centimeters
Weight gain Through study intervention, an average of 4 weeks Assessment of daily weight in grams
Head growth Through study intervention, an average of 4 weeks Assessment of weekly head circumference in centimeters
Neurodevelopmental Outcomes 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
Pain scores 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.
Trial Locations
- Locations (1)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States