Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis (NCT05991648) | Clinical Trial Compass
UnknownNot Applicable
Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis
Colombia20 participantsStarted 2023-07-15
Plain-language 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. However, premature neonates exhibit immaturity of the autonomic nervous system, which could increase the risk of sepsis. Kangaroo Care (skin-to-skin contact) may promote autonomic nervous system modulation and maturation in preterm newborns with sepsis. The objective of this study is to determine the effect of Kangaroo Care on heart rate variability in preterm newborns with late-onset clinical sepsis.
Methods: A cross-over randomized clinical trial will be conducted, including 20 preterm infants with late-onset sepsis. The autonomic nervous system will be assessed using heart rate variability analysis. The study interventions consist of routine care in an incubator and Kangaroo Care. Randomization will be performed using a four-block permuted design for the two intervention sequences AB: Kangaroo Care - incubator care, or BA: incubator care - Kangaroo Care. Heart rate variability will be recorded using a Polar Rs800 monitor and analyzed with Kubios software.
Discussion: This study will provide information on the relationship between Kangaroo Care and autonomic nervous system activity in preterm neonates with late-onset sepsis. These data will contribute to the understanding of the cholinergic anti-inflammatory reflex in neonates and the capacity of skin-to-skin contact to modulate autonomic activity in neonatal infection. Thus, the study seeks to provide initial evidence for the use of skin-to-skin contact as a non-pharmacological therapeutic intervention in neonatal sepsis.
Who can participate
Age range
26 Weeks – 36 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is studying kangaroo care — skin-to-skin holding — for newborns with late-onset neonatal sepsis, is my baby's current condition stable enough to safely participate in hands-on contact like this?
2This trial is measuring heart rate variability as an outcome, which can reflect how stressed or recovering a baby's nervous system is — can you help me understand what that means for my baby's specific situation and whether it's a meaningful signal to track?
3The recruitment status for this trial is listed as unknown, so before we consider it, can you find out whether it is actually still enrolling babies and where the nearest participating site is?
4This trial is listed as Phase NA, which often means it's studying a care practice rather than a drug — does that change the risk profile compared to standard treatment, and would my baby still receive full sepsis treatment either way?
5Are there standard-of-care approaches to managing late-onset neonatal sepsis that we should try first, or is participating in this kind of study something that could run alongside the treatment my baby is already receiving?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.