Prematurity, Stress Reaction
Conditions
Keywords
preterm infant, stress, nursing care, touch
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.
Interventions
BEHAVIORALNurse-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.
Sponsors
Nationwide Children's Hospital
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The statistician performing the data analysis will be blinded to group.
Intervention model description
randomized cross-over design
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Heart Rate -- During Intervention | during intervention or control period, approximately 20 minutes | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period |
| Average Heart Rate -- Recovery | recovery, 30 minutes after intervention delivery or control period | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average High-frequency Heart Rate Variability -- During Caregiving Episode | during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes | Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. |
| Average High-frequency Heart Rate Variability -- Recovery | recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care | Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. |
| Average Frequency of Skin Conductance Responses -- During Caregiving Episode | during caregiving episode, approximately 20 minutes | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving. |
| Average Frequency of Skin Conductance Responses -- Recovery | recovery, 30 minutes after intervention delivery or control period | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Nurse-Administered Touch Intervention, Then Standard Care Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care.
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.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine. | 10 |
| Experimental: Standard Care, Then Nurse-Administered Touch Intervention Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive an episode of essential nursing care that includes the nurse-administered touch intervention.
Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine.
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. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | withdrawn for transfer | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental: Nurse-Administered Touch Intervention, Then Standard Care | Experimental: Standard Care, Then Nurse-Administered Touch Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 28.9 weeks gestation at birth | 28.7 weeks gestation at birth | 28.8 weeks gestation at birth |
| Birthweight | 1339 grams | 1158.4 grams | 1253.5 grams |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 6 Participants | 15 Participants |
| Region of Enrollment United States | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 5 / 19 | 8 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
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
Time frame: during intervention or control period, approximately 20 minutes
Population: 19 enrolled infants in randomized cross-over trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-Administered Touch Intervention | Average Heart Rate -- During Intervention | 172.6 beats per minute | Standard Deviation 10.5 |
| Standard Care | Average Heart Rate -- During Intervention | 168.6 beats per minute | Standard Deviation 9.2 |
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
Time frame: recovery, 30 minutes after intervention delivery or control period
Population: 19 total infants participated in randomized cross-over trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-Administered Touch Intervention | Average Heart Rate -- Recovery | 161.7 beats per minute | Standard Deviation 10 |
| Standard Care | Average Heart Rate -- Recovery | 158.6 beats per minute | Standard Deviation 8.4 |
Secondary
Average Frequency of Skin Conductance Responses -- During Caregiving Episode
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving.
Time frame: during caregiving episode, approximately 20 minutes
Population: 19 total participants in randomized cross-over trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-Administered Touch Intervention | Average Frequency of Skin Conductance Responses -- During Caregiving Episode | 0.14 waves per second | Standard Deviation 0.05 |
| Standard Care | Average Frequency of Skin Conductance Responses -- During Caregiving Episode | 0.14 waves per second | Standard Deviation 0.05 |
Secondary
Average Frequency of Skin Conductance Responses -- Recovery
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period.
Time frame: recovery, 30 minutes after intervention delivery or control period
Population: 19 total participants in randomized cross-over trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-Administered Touch Intervention | Average Frequency of Skin Conductance Responses -- Recovery | 0.06 waves per second | Standard Deviation 0.04 |
| Standard Care | Average Frequency of Skin Conductance Responses -- Recovery | 0.06 waves per second | Standard Deviation 0.05 |
Secondary
Average High-frequency Heart Rate Variability -- During Caregiving Episode
Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Time frame: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes
Population: 19 total participants in randomized cross-over trial
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-Administered Touch Intervention | Average High-frequency Heart Rate Variability -- During Caregiving Episode | 3.2 ln(ms^2) |
| Standard Care | Average High-frequency Heart Rate Variability -- During Caregiving Episode | 3.2 ln(ms^2) |
Secondary
Average High-frequency Heart Rate Variability -- Recovery
Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Time frame: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care
Population: 19 total participants in randomized cross-over trial
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-Administered Touch Intervention | Average High-frequency Heart Rate Variability -- Recovery | 3.0 ln(ms^2) |
| Standard Care | Average High-frequency Heart Rate Variability -- Recovery | 3.0 ln(ms^2) |