Clinical trial NCT04368767: A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Baby 33 to 36 Weeks
Mother-Infant Interaction
Oxidative Stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stress biomarkers
timeFrame: Day 3
measure: Stress biomarkers
timeFrame: Day 2
measure: Stress biomarkers
timeFrame: Day 1
Secondary outcomes:
measure: Mother's Satisfaction with SSC
timeFrame: Day 3
measure: Number of discomforting and stressful events for mother
timeFrame: Day 3
measure: Number of discomforting and stressful events for mother
timeFrame: Day 2
measure: Number of discomforting and stressful events for mother
timeFrame: Day 1
measure: Number of discomforting and stressful events for infant
timeFrame: Day 3
measure: Number of discomforting and stressful events for infant
timeFrame: Day 2
measure: Number of discomforting and stressful events for infant
timeFrame: Day 1
measure: Change in stress biomarkers
timeFrame: pre and post the intervention on days 1, 2, and 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda Franck, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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