Pilot Study of Nursing Touch and Biobehavioral Stress

Prematurity Clinical Trial

— P-NAT-BIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030233
• Other study ID #: 2021N0006
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 17, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Stress
• Prematurity
• Stress Reaction

Intervention

Behavioral:
• Nurse-Administered Touch Intervention
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neurobehavior	neurobehavior will be assessed using the Neurobehavioral Assessment of the Preterm Infant when infants reach 35 weeks post-menstrual age	35 weeks post-menstrual age
Other	Anderson Behavioral State Scale	behavioral states (ranging from quiet sleep to crying) will be measured during the recovery period as a further behavioral measure of infant recovery from essential nursing care	recovery, 30 minutes after intervention delivery or control period
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Salivary cortisol	saliva will be collected using cellulose surgical sponges and quantified by enzyme-linked immunosorbent assay	immediately after intervention or control period
Secondary	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