Heart Rate Variability of Premature Newborn (HRV)

Federal University of Uberlandia

Status: Not yet enrolling

Conditions: Autonomic Nervous System Imbalance

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06217133

Federal University Uberlandia

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

control group

No Intervention group

Description:

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.

CPAP Group

Active Comparator group

Description:

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

Treatment:

Device: CPAP