Clinical trial NCT05030233: Pilot Study of Nursing Touch and Biobehavioral Stress
Official title: Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Stress Reaction
Keywords: preterm infant
stress
nursing care
touch
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2021-09-01
Enrollment: 19
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized cross-over design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.

Detailed description: Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.

Eligibility criteria: Inclusion Criteria:

* Born prematurely between 27 and 30 weeks post-menstrual age.
* Born to mothers who are English-speaking and able to provide informed consent.
* No more than 10 days old at the time of enrollment.

Exclusion Criteria:

* Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
* Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
* Receiving scheduled steroids or vasopressors.
* Skin conditions that preclude the attachment of sensors.
* Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
* Diagnosed with chromosomal abnormalities.
* Requiring special isolation with universal gloving for potentially infectious pathogens.

Primary outcomes:
measure: Average Heart Rate -- During Intervention
timeFrame: during intervention or control period, approximately 20 minutes
measure: Average Heart Rate -- Recovery
timeFrame: recovery, 30 minutes after intervention delivery or control period
Secondary outcomes:
measure: Average High-frequency Heart Rate Variability -- During Caregiving Episode
timeFrame: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes
measure: Average High-frequency Heart Rate Variability -- Recovery
timeFrame: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care
measure: Average Frequency of Skin Conductance Responses -- During Caregiving Episode
timeFrame: during caregiving episode, approximately 20 minutes
measure: Average Frequency of Skin Conductance Responses -- Recovery
timeFrame: recovery, 30 minutes after intervention delivery or control period
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Marliese D. Nist, PhD
role: PRINCIPAL_INVESTIGATOR
References: