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Effect of Kangaroo Care on Heart Rate Variability in Late-onset Neonatal Sepsis

NCT05991648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Late-Onset Neonatal Sepsis

Interventions

PROCEDURE

Kangaroo Care (skin-to-skin contact)

Skin-to-skin contact between the mother and the child. The naked newborn, wearing only a diaper and a hat, is placed in a vertical position in direct contact between the mother's breasts. An elastic fabric support (made of cotton or synthetic elastic fiber) will be used to facilitate the position.

Sponsors & Collaborators

  • Clínica Palermo

    collaborator UNKNOWN

  • Hospital Meissen

    collaborator UNKNOWN

  • Universidad de la Sabana

    lead OTHER

Principal Investigators

  • Sergio Agudelo, PhD · Universidad de la Sabana

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
26 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2024-12-01
Completion
2025-11-01

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05991648 on ClinicalTrials.gov