Pilot Study of Nursing Touch and Biobehavioral Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants

Conditions
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Prematurity, Stress Reaction

Intervention / Treatment
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* Behavioral: Nurse-Administered Touch Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized cross-over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-Administered Touch Intervention<br>Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care. | Behavioral: Nurse-Administered Touch Intervention<br>* The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.<br>|
| No Intervention: Standard Care<br>Preterm infants will receive one episode of essential nursing care delivered as standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average heart rate -- during intervention | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | during intervention or control period, approximately 20 minutes | 
| Average heart rate -- recovery | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | recovery, 30 minutes after intervention delivery or control period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average heart rate variability -- during intervention | high frequency heart rate variability averaged over the intervention or control period | during intervention or control period, approximately 20 minutes | 
| Average heart rate variability -- recovery | high frequency heart rate variability averaged over the intervention or control period | recovery, 30 minutes after intervention delivery or control period | 
| Average skin conductance responses -- during intervention | skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period | during intervention or control period, approximately 20 minutes | 
| Average skin conductance responses -- recovery | skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the intervention or control period | recovery, 30 minutes after intervention delivery or control period | 
| Salivary cortisol | saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay | immediately after intervention or control period | 
| Salivary cortisol -- recovery | saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay | recovery, 60 minutes after intervention delivery or control period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infant, stress, nursing care, touch