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

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Skin-to-skin

Study type: Interventional

Funder types: Other

Identifiers

NCT04368767

19-29543

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Usual Care: Incubator

No Intervention group

Description:

The infant will remain in the incubator and stress biomarkers will be collected per protocol

Intervention: Skin-to-skin

Experimental group

Description:

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.

Treatment:

Behavioral: Skin-to-skin