Massage Therapy, Neonatal Prematurity
Conditions
Keywords
Prematurity, Massage therapy
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.
Interventions
OTHERNeonatal Touch and Massage Therapy
Structured touch and massage therapy performed by certified providers.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors evaluating neurodevelopmental outcomes will be masked from knowing which intervention was assigned to individual participants.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | Through study intervention, an average of 4 weeks | Assessment of daily weight in grams |
| Linear growth | Through study intervention, an average of 4 weeks | Assessment of weekly length in centimeters |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohana Diaz, MD
University of Maryland, Baltimore
Outcome results
None listed