Status:
UNKNOWN
Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis
Lead Sponsor:
Universidad de la Sabana
Collaborating Sponsors:
Clínica Palermo
Hospital Meissen
Conditions:
Late-Onset Neonatal Sepsis
Eligibility:
All Genders
26-36 years
Phase:
NA
Brief Summary
Background: Neonatal sepsis is the leading cause of mortality in preterm newborns. The autonomic nervous system modulates the response to sepsis through the cholinergic anti-inflammatory reflex. Howev...
Detailed Description
* The autonomic nervous system (ANS) plays a fundamental role in modulating the immune inflammatory response to infection. * Premature neonates have immaturity in the development of the ANS at birth, ...
Eligibility Criteria
Inclusion
- Newborns with Ballard gestational age less than 37 weeks
- Older than 72 hours
- Hospitalized since birth in the neonatal unit
- Diagnosed with late-onset clinical sepsis
- Weighing between ≥1200 and ≤2500 g.
- Colombian Association of Neonatology (ASCON) criteria will be used to define late-onset clinical sepsis
Exclusion
- Neonates with cardiovascular or neurological congenital anomalies,
- Respiratory and/or hemodynamic clinical instability, including the need for invasive mechanical ventilation, respiratory lability, hypotension, and/or the need for vasopressor medications.
Key Trial Info
Start Date :
July 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05991648
Start Date
July 15 2023
End Date
November 1 2025
Last Update
August 14 2023
Active Locations (3)
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1
Clinica Palermo
Bogotá, Bogota D.C., Colombia, 111311
2
Universidad de La Sabana
Chía, Cundinamarca, Colombia, 140013
3
Hospital Meissen
Bogotá, Colombia, 110621