Status:
RECRUITING
Family Centred Healthcare - Zero Separation and Couplet Care
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborating Sponsors:
University of Copenhagen
Conditions:
Premature Birth
Post Partum
Eligibility:
All Genders
Phase:
NA
Brief Summary
Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus...
Detailed Description
"There is no such thing as a baby, there is a baby and someone". Approximately 10% of all newborn infants are admitted to a neonatal intensive care unit (NICU) for medical reasons and care, due to si...
Eligibility Criteria
Inclusion
- Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production and infection.
- Infant from gestational age 28 weeks with a treatment-requiring condition such as respiratory distress syndrome (with respiratory support including mechanical ventilation), hyperbilirubinemia, infection, and low blood sugar.
Exclusion
- Healthy mothers who does not need care and treatment, and has an infant admitted at NICU.
- Mothers who are admitted at an adult intensive care unit due to severe sickness (severe preeclampsia with spasm, severe bleeding of 4-5 liter, and severe HELLP syndrome) - counting one-two mothers a year
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT05236023
Start Date
June 14 2022
End Date
August 31 2026
Last Update
August 21 2024
Active Locations (1)
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1
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650