Pilot Study of Nursing Touch and Biobehavioral Stress (P-NAT-BIO)

The Ohio State University

Status: Completed

Conditions: Prematurity; Stress Reaction

Treatments: Behavioral: Nurse-Administered Touch Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05030233

2021N0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: Under 10 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Nurse-Administered Touch Intervention

Experimental group

Description:

Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care.

Treatment:

Behavioral: Nurse-Administered Touch Intervention

Standard Care

No Intervention group

Description:

Preterm infants will receive one episode of essential nursing care delivered as standard care.