Clinical trial NCT06217133: Heart Rate Variability of Premature Newborn
Official title: Heart Rate Variability of Premature Newborn Subject to Two CPAP Methods
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Keywords: Heart rate variability
Neonatal intensive care unit
Non-invasive ventilation
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
Collaborators: name: Adriano de Oliveira Andrade
First posted: 2024-01-22
Enrollment: 65
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The researchers will compare the conventional CPAP and bubble CPAP group according to randomization.

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.All participants will be evaluated on two different days, on one day data collection will be carried out using conventional CPAP and on the other day bubble CPAP according to randomization. The days will be consecutive and premature babies will remain on each type of CPAP for 24 hours.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: HRV variables in time domains
timeFrame: A total of two evaluation days will be carried out, which will be divided into: 1 full hour in the morning, afternoon and evening, totaling 3 hours for each consecutive evaluation day
measure: Frequency domain variables
timeFrame: A total of two evaluation days will be carried out, which will be divided into: 1 full hour in the morning, afternoon and evening, totaling 3 hours for each consecutive evaluation day
measure: The non-linear parameters of heart rate variability
timeFrame: total of two evaluation days will be carried out, which will be divided into: 1 full hour in the morning, afternoon and evening, totaling 3 hours for each consecutive evaluation day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Uberlandia
name: Lilian Rodrigues de Abreu Macedo, 3
role: STUDY_CHAIR
References: