A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
- Conditions
- Premature Baby 33 to 36 WeeksMother-Infant InteractionOxidative Stress
- Registration Number
- NCT04368767
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stress biomarkers Day 1 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.
- Secondary Outcome Measures
Name Time Method Number of discomforting and stressful events for mother Day 1 Total count of discomfort and stressful events
Number of discomforting and stressful events for infant Day 1 Total count of discomforting and stressful events
Mother's Satisfaction with SSC Day 3 Mother's Satisfaction with SSC Questionnaire
Change in stress biomarkers pre and post the intervention on days 1, 2, and 3 salivary cortisol, urinary biomarkers of Hx, Xa, Uric Acid (UA), and allantoin and stress buffering (i.e., salivary oxytocin
Trial Locations
- Locations (1)
UCSF Benioff Children's Hospital San Francisco
🇺🇸San Francisco, California, United States
UCSF Benioff Children's Hospital San Francisco🇺🇸San Francisco, California, United States