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

NCT05991648 | Unknown DMC

• 1 other identifier: Acta 589 4 de noviembre 2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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. 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

Keywords

Infant, Newborn; Kangaroo-Mother Care Method; Heart Rate Variability; Autonomic Nervous System; Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Change in the mean HRV analysis indices between the two interventions.

  60 minutes

Secondary Outcomes (1)

• SCRIP

  60 minutes

Study Arms (2)

Kangaroo Care (skin-to-skin contact)

EXPERIMENTAL

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.

Procedure: Kangaroo Care (skin-to-skin contact)

Routine care in an incubator

NO INTERVENTION

The newborn, dressed only in a clean diaper, is placed in a nest in the double-walled servo-controlled incubator.

Interventions

Kangaroo Care (skin-to-skin contact) PROCEDURE

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.

Kangaroo Care (skin-to-skin contact)

Eligibility Criteria

• Age: 26 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de la Sabana: lead
• Clínica Palermo: collaborator
• Hospital Meissen: collaborator

Study Sites (3)

Clinica Palermo

Bogotá, Bogota D.C., 111311, Colombia

RECRUITING

Universidad de La Sabana

Chía, Cundinamarca, 140013, Colombia

NOT YET RECRUITING

Hospital Meissen

Bogotá, 110621, Colombia

NOT YET RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio Agudelo, PhD

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio I Agudelo, PhD

CONTACT

57(1)3105612142; sergioagpe@unisabana.edu.co

Valentina Perez, Dr.

CONTACT

57(1)3183327127; mariapeva@unisabana.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking will not be applied due to the nature of the interventions. However, blinding of the intervention sequence will be maintained for the researchers responsible for data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once the newborn's enrollment in the study is confirmed, procedures for HRV recording will be initiated, following the procedure below. Randomization of the newborn to the intervention sequence will be performed accordingly: sequence AB as Kangaroo Care - incubator care, or sequence BA as incubator care - Kangaroo Care. The HRV signal will be obtained using a Polar H10 chest strap connected via Bluetooth to the Polar RS800 monitor. In the RR function, the accuracy is less than 1 millisecond per beat. The chest strap will be placed on the anterior region of the newborn's chest (Figure 1). Before the start of data recording, a stabilization period of 30 minutes in the assigned intervention sequence will be allowed. After this period, HRV recording will begin using the Polar monitor for 60 minutes for each intervention. Before changing the intervention sequence, a washout period of three hours will be allowed

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: July 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (3)