Infant Massage in the NICU

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Prematurity, Massage Therapy

Intervention / Treatment
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* Other: Neonatal Touch and Massage Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Structured touch and massage therapy performed by certified providers.<br>|
| No Intervention: Control<br>This group will receive standard NICU care, no different than if they were not enrolled in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | 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 | Assessment of daily weight in grams | Through study intervention, an average of 4 weeks | 
| Linear growth | Assessment of weekly length in centimeters | Through study intervention, an average of 4 weeks | 
| Head growth | Assessment of weekly head circumference in centimeters | Through study intervention, an average of 4 weeks | 
| Neurodevelopmental Outcomes | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage therapy, Prematurity