Effects of Neonatal Therapeutic Touch and Massage in Very Preterm and Extremely Preterm Neonates: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Neonatal Touch and Massage Therapy
- Conditions
- Neonatal Prematurity
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Length of stay
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Johana Diaz
Assistant professor of pediatrics, Division of neonatology, University of Maryland
University of Maryland, Baltimore
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: Neonatal Touch and Massage Therapy
Control
This group will receive standard NICU care, no different than if they were not enrolled in the study.
Outcomes
Primary Outcomes
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
- Linear growth(Through study intervention, an average of 4 weeks)
- Weight gain(Through study intervention, an average of 4 weeks)
- Head growth(Through study intervention, an average of 4 weeks)
- Neurodevelopmental Outcomes(Within in 1 week of NICU discharge or transfer until up to 3 years of age)
- Pain scores(1 hour before intervention and up to 3 hours post-intervention)