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

Not Applicable

Completed

• Conditions: Premature Baby 33 to 36 Weeks; Mother-Infant Interaction; Oxidative Stress
• Interventions: Behavioral: Skin-to-skin

• 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

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2020-08-03
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Skin-to-skin	Skin-to-skin	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.

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