Infant Massage in the NICU
Purpose
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.
Conditions
- Neonatal Prematurity
- Massage Therapy
Eligibility
- Eligible Ages
- Between 24 Weeks and 32 Weeks
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized controlled trial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Assessors evaluating neurodevelopmental outcomes will be masked from knowing which intervention was assigned to individual participants.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
|
No Intervention Control |
This group will receive standard NICU care, no different than if they were not enrolled in the study. |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
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.