Other Clinical Trial - Heart Rate Variability of Premature Newborn

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Autonomic Nervous System Imbalance
Premature Birth

Clinical Trial Details

NCT number	NCT06217133
Study type	Interventional
Source	Federal University of Uberlandia
Contact	Letícia de Queiroz Martins, 3
Phone	55 (34) 32182112
Email	leticiaqm.fisio@hotmail.com
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2024
Completion date	June 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Heart Rate Variability of Premature Newborn — HRV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms