Heart Rate Variability of Premature Newborn Subject to Two CPAP Methods
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 主要终点
- HRV variables in time domains
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HRV variables in time domains
时间窗: 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
The time domain variables are: average of RR intervals (Mean RR) expressed in milliseconds (ms); average beats per minute (Mean HR) expressed in (bpm); standard deviation of all normal RR intervals (SDNN) expressed in (ms); square root of the mean square differences between successive RR intervals (RMSSD) expressed in (ms); percentage of adjacent RR intervals with a difference in duration greater than 50 ms (pNN50) expressed in percentage (%).
Frequency domain variables
时间窗: 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
The frequency domain variables are: very low frequency (VLF) expressed in hertz (Hz); low frequency (LF) expressed in Hz; high frequency (HF) expressed in Hz.
The non-linear parameters of heart rate variability
时间窗: 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
The non-linear parameters of heart rate variability are: short-term (instantaneous) beat-to-beat RR variability of the Poincaré plot (SD1) expressed in milliseconds (ms); long-term (continuous) beat-to-beat variability of the Poincaré plot (SD2) also expressed in ms and the SD2/SD1 ratio.
次要结局
未报告次要终点
研究者
Letícia de Queiroz Martins
Letícia de Queiroz Martins
Federal University of Uberlandia