Status:
COMPLETED
Evaluating the Effects of Kangaroo Care in the NICU
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Northwestern University
Conditions:
Kangaroo Care
Premature Birth
Eligibility:
All Genders
1-20 years
Brief Summary
The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact acute physiologic and long-term behavioral outcomes in infants, fathers, and families.
Detailed Description
Screening: Participants will be recruited from the NICU at Prentice Women's Hospital. A member of the study team will screen all NICU patients for inclusion and exclusion criteria by reviewing electr...
Eligibility Criteria
Inclusion
- Infants: Infants who are born at Prentice Women's Hospital between 30 0/7 and 36 6/7 weeks gestation, are ≤20 days old at the time of enrollment, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, infants will only be included in this study if both of their biological parents are eligible and agree to participate.
- Parents: Parents who are ≥18 years of age, English speaking, expect mother and father to raise the infant together in the same household regardless of their marital status, and do not meet any of the study's exclusion criteria will be eligible for participation in this study. Additionally, family units will only be included in this study if both biological parents of the infant are eligible and agree to participate. Only English speaking parents will be included in this trial because the study questionnaires are only available in English.
Exclusion
- Infants: Infants who are intubated or sedated, are receiving vasopressors or analgesics, have any congenital anomalies or skin abnormalities deemed likely to impact KC by clinical team, have received or are planned to receive surgical intervention, or are experiencing other symptoms or receiving other intervention that will impact the utilization of KC, wearable sensors, and/or oral swabs will be excluded from this study.
- Parents: Parents who are showing any signs of illness or taking corticosteroids or testosterone supplementation will be excluded from this study. Non-English speaking parents will also be excluded from this study because the questionnaires associated with this study are only available in English.
Key Trial Info
Start Date :
May 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04727125
Start Date
May 17 2019
End Date
January 1 2022
Last Update
March 10 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, United States, 60611