Status:
COMPLETED
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
Lead Sponsor:
University of California, San Francisco
Conditions:
Premature Baby 33 to 36 Weeks
Mother-Infant Interaction
Eligibility:
All Genders
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04368767
Start Date
August 3 2020
End Date
September 30 2020
Last Update
November 12 2020
Active Locations (1)
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1
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, United States, 94158