Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life. The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Skin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, usually in the afternoon. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. After pre-intervention measures of axillary temperature, heart rate, respiratory rate, and oxygen saturation by pulse oximetry (SPO2) are obtained; cotton balls placed in the diaper for urine collection will be removed and stored in an appropriate container. Salivary oxytocin and cortisol will be collected per protocol below. Mothers will be requested to sit in reclining chairs with a front opened blouse or hospital gown. Infants will be removed from the incubator and placed naked except for a diaper and hat directly onto the skin between the mother's breasts and covered with a blanket. All infants will be monitored. After the two hours of SSC is completed, the infant will be returned to the incubator.
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, United States
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Time frame: Day 3
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Time frame: Day 2
Stress biomarkers
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Time frame: Day 1
Mother's Satisfaction with SSC
Mother's Satisfaction with SSC Questionnaire
Time frame: Day 3
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Time frame: Day 3
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Time frame: Day 2
Number of discomforting and stressful events for mother
Total count of discomfort and stressful events
Time frame: Day 1
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Time frame: Day 3
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Time frame: Day 2
Number of discomforting and stressful events for infant
Total count of discomforting and stressful events
Time frame: Day 1
Change in stress biomarkers
salivary cortisol, urinary biomarkers of Hx, Xa, Uric Acid (UA), and allantoin and stress buffering (i.e., salivary oxytocin
Time frame: pre and post the intervention on days 1, 2, and 3
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