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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04368767

Run by

University of California, San Francisco

People needed

8

Starts

2020-08-03

Expected to finish

2020-09-30

Last updated by the study team

2020-11-12

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Benioff Children's Hospital San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.