A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact Compared to Standard Care on the Stress Responses of Late Preterm Infants in the First Week of Life

Conditions
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Premature Baby 33 to 36 Weeks, Mother-Infant Interaction, Oxidative Stress

Intervention / Treatment
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* Behavioral: Skin-to-skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9 Mothers able to read and write English Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours Exclusion Criteria: Surgery in the first week of life Intraventricular hemorrhage (IVH) of grade 3 or 4 Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin Plasma creatinine of >1 mg/dl Severe cyanotic heart disease or severe respiratory distress Abdominal wall or intestinal anomaly or injury (NEC) Facial anomaly or other known chromosomal anomaly Life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will use a randomized controlled trial design to examine feasibility of the prolonged SSC intervention in the first week of life for late preterm infants and to provide preliminary data for future research to compare the effects of usual incubator care with prolonged SSC on biomarkers of stress in late preterm infants in the first week of life.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care: Incubator<br>The infant will remain in the incubator and stress biomarkers will be collected per protocol | |
| Experimental: Intervention: Skin-to-skin<br>Skin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, 30 minutes after feeding. SSC will usually occur in the afternoon between 11:30-12:30 pm or 14:30-15:30pm. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. The room will be monitored to maintain a temperature of 72-77 degrees Fahrenheit during SSC. Stress biomarkers will be collected per protocol. | Behavioral: Skin-to-skin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother's Satisfaction with SSC | Mother's Satisfaction with SSC Questionnaire | Day 3 | 
| Number of discomforting and stressful events for mother | Total count of discomfort and stressful events | Day 3 | 
| Number of discomforting and stressful events for mother | Total count of discomfort and stressful events | Day 2 | 
| Number of discomforting and stressful events for mother | Total count of discomfort and stressful events | Day 1 | 
| Number of discomforting and stressful events for infant | Total count of discomforting and stressful events | Day 3 | 
| Number of discomforting and stressful events for infant | Total count of discomforting and stressful events | Day 2 | 
| Number of discomforting and stressful events for infant | Total count of discomforting and stressful events | 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 | pre and post the intervention on days 1, 2, and 3 |