Kangaroo Care's effect on heart rate in preterm infants with sepsis
Effect of Kangaroo Care (Skin-to-skin Contact) on Heart Rate Variability in Preterm Infants With Late Neonatal Sepsis: a Randomized Crossover Clinical Trial
NA · Universidad de la Sabana · NCT05991648
This study tests if skin-to-skin contact, known as Kangaroo Care, can help improve heart rate in preterm infants who have sepsis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 26 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Universidad de la Sabana (other) |
| Locations | 3 sites (Bogotá, Bogota and 2 other locations) |
| Trial ID | NCT05991648 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Kangaroo Care, which involves skin-to-skin contact between preterm infants and their caregivers, on heart rate variability in newborns diagnosed with late-onset neonatal sepsis. The research employs a cross-over randomized clinical trial design, including 20 preterm infants who will receive both Kangaroo Care and routine incubator care in a randomized sequence. The study aims to assess changes in the autonomic nervous system's response to sepsis through heart rate variability analysis and the stability of the cardiorespiratory system. The findings could provide insights into non-pharmacological interventions for improving outcomes in preterm infants with sepsis.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm newborns with a gestational age of less than 37 weeks, diagnosed with late-onset clinical sepsis, and weighing between 1200 and 2500 grams.
Not a fit: Patients with congenital cardiovascular or neurological anomalies, or those experiencing respiratory and hemodynamic instability, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the autonomic nervous system's function and improve clinical outcomes for preterm infants suffering from sepsis.
How similar studies have performed: While the use of Kangaroo Care has been explored in various contexts, this specific application in late-onset neonatal sepsis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Bogotá, Bogota and 2 other locations
- Clinica Palermo — Bogotá, Bogota, Colombia (RECRUITING)
- Universidad de La Sabana — Chía, Cundinamarca, Colombia (NOT_YET_RECRUITING)
- Hospital Meissen — Bogotá, Colombia (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Sergio Agudelo, PhD — Universidad de la Sabana
- Study coordinator: Sergio I Agudelo, PhD
- Email: sergioagpe@unisabana.edu.co
- Phone: 57(1)3105612142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Late-Onset Neonatal Sepsis, Infant, Newborn, Kangaroo-Mother Care Method, Heart Rate Variability, Autonomic Nervous System, Neonatal Sepsis