Clinical trial NCT06163586: Massage Therapy in Premature Neonates
Official title: Effects of Neonatal Therapeutic Touch and Massage in Very Preterm and Extremely Preterm Neonates: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neonatal Prematurity
Massage Therapy
Keywords: Prematurity
Massage therapy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 32
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Length of stay
timeFrame: Day of birth to discharge home, up to 6 months
Secondary outcomes:
measure: Weight gain
timeFrame: Through study intervention, an average of 4 weeks
measure: Linear growth
timeFrame: Through study intervention, an average of 4 weeks
measure: Head growth
timeFrame: Through study intervention, an average of 4 weeks
measure: Neurodevelopmental Outcomes
timeFrame: Within in 1 week of NICU discharge or transfer until up to 3 years of age
measure: Pain scores
timeFrame: 1 hour before intervention and up to 3 hours post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Johana Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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