Heart Rate Variability of Premature Newborn

NCT ID: NCT06217133

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

Brief Summary

To analyze the effects of two CPAP methods on the HRV of PTNBs during their routine routine in the HCUFU neonatal ICU. This is a randomized clinical trial, with controlled groups and cross over with healthy term newborns (RNT) as a control group admitted to the HC-UFU rooming-in and premature newborns (PTRN), between 28 and 32 weeks pregnant women with nasal CPAP group admitted to the neonatal ICU of the same hospital. The HRV recorded by the POLAR® RS800cx cardiac monitor will be analyzed, with a sampling rate of 1000 Hz.

The main question[s] it aims to answer are:

• Is there a difference in heart rate variability between newborns using conventional nasal CPAP and nasal bubble CPAP?
• Is it possible to conclude that one of the methods has a greater sympathetic or parasympathetic tone compared to the other?

Premature participants will be in the incubators in a supine position with 30 minutes rest after the last handling. Each data collection will last 60 minutes and will be carried out three times a day in the morning, afternoon and night shifts, for each 1-hour collection, HRV will be analyzed in 12 5-minute intervals, establishing an average for each variable of the data. HRV during a 1-hour period.

The researchers will compare the conventional CPAP and bubble CPAP group according to randomization.

• In the control group, data collection will be carried out in the Rooming Room in a single reference collection lasting 20 minutes, and analyzed in 4 5-minute intervals.
• The participant selected for conventional CPAP will receive conventional CPAP for 24 hours, then receive bubble CPAP for 24 hours the following day. The opposite will be done for the participant drawn for CPAP bubbles.

The comparison between the conventional CPAP and bubble CPAP groups will occur to find out whether it is possible to identify the type of non-invasive ventilation that allows an increase in HRV and parasympathetic tone variables, as well as a reduction in sympathetic tone variables and the stress index of premature babies.

Conditions

Autonomic Nervous System Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

control group

The analysis of heart rate variability will be carried out in theIn the control group (NT), data collection will be carried out in the Rooming Room in a single reference collection lasting 20 minutes, and analyzed in 4 5-minute intervals. Newborns will be full term and will be in the supine position, lying in the common crib and resting. All collections for this group will be carried out in the afternoon on a day to be agreed with the mother or responsible companion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CPAP Group

The analysis of heart rate variability will be carried out in the in the CPAP group, conventional and in the bubble CPAP.

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

Conventional CPAP will be administered according to the unit's routine on ventilators of different brands and models according to service availability. Binary prongs, from brands available in the service, will be used as an interface without touching the nasal septum with the size recommended by the manufacturer and in accordance with the protocol established in the unit.

TThe CPAP bubbles will be administered using the CPAP NEONATAL BABYPAP® MODEL 1150 S equipment, which is an electromedical device for non-invasive ventilatory assistance for newborns that generates continuous pressure in the airways (CPAP) controlled by means of a column of water that bubbles, through a flow of heated and humidified medical gas mixture supplied by a breathing circuit to the patient's nasal passage.

Interventions

CPAP

Conventional CPAP will be administered according to the unit's routine on ventilators of different brands and models according to service availability. Binary prongs, from brands available in the service, will be used as an interface without touching the nasal septum with the size recommended by the manufacturer and in accordance with the protocol established in the unit.

TThe CPAP bubbles will be administered using the CPAP NEONATAL BABYPAP® MODEL 1150 S equipment, which is an electromedical device for non-invasive ventilatory assistance for newborns that generates continuous pressure in the airways (CPAP) controlled by means of a column of water that bubbles, through a flow of heated and humidified medical gas mixture supplied by a breathing circuit to the patient's nasal passage.

Intervention Type: DEVICE

Other Intervention Names

continuous positive airway pressure

Eligibility Criteria

Inclusion Criteria

• All preterm infants between 28 and 32 weeks of gestation using nasal CPAP and who are at least 8 and at most 12 days old will be included in the study.

Exclusion Criteria

• hemodynamic instability,
• hydroelectrolyte disorders that influence cardiac function,
• post-operative,
• congenital abnormalities,
• pulmonary hypertension,
• decompensated ductus arteriosus,
• untreated atelectasis,
• pneumothorax,
• newborns who are using drains, whether chest or abdominal,
• presence of necrotizing enterocolitis
• grade 3 nasal septum injury,
• signal captured without the necessary quality to be used in research,
• premature babies who, for whatever reason, do not have two collections carried out on consecutive days until the twelfth day of life.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adriano de Oliveira Andrade

UNKNOWN

Sponsor Role: collaborator

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Letícia de Queiroz Martins

Letícia de Queiroz Martins

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilian Rodrigues de Abreu Macedo, 3

Role: STUDY_CHAIR

Federal University of Uberlandia

Central Contacts

Letícia de Queiroz Martins, 3

Role: CONTACT

leticiaqm.fisio@hotmail.com

55 (34) 32182112

Adriano de Oliveira Andrade, 3

Role: CONTACT

adriano@ufu.br

55 (34) 3239-4709

Other Identifiers

Federal University Uberlandia

Identifier Type: -

Identifier Source: org_study_id