Heart Rate Variability of Premature Newborn
NCT06217133 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2024-01-22
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
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Adriano de Oliveira Andrade
collaborator UNKNOWN -
Federal University of Uberlandia
lead OTHER
Principal Investigators
-
Lilian Rodrigues de Abreu Macedo, 3 · Federal University of Uberlandia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 28 Weeks
- Max Age
- 32 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2025-05-31
- Completion
- 2025-06-01
More Related Trials
-
Premature Infant Exposure to Noise Generated by Respiratory Support
NCT01748214 ·Status: COMPLETED
-
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
NCT05706428 ·Status: COMPLETED ·Phase: NA
-
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
NCT06693817 ·Status: RECRUITING ·Phase: NA
-
NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV
NCT02860325 ·Status: COMPLETED ·Phase: NA
-
Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
NCT03174301 ·Status: COMPLETED
-
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
NCT04920175 ·Status: COMPLETED
-
Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination
NCT01256346 ·Status: WITHDRAWN
-
Work of Breathing During Non-invasive Ventilation in Premature Neonates
NCT02788110 ·Status: COMPLETED ·Phase: NA
-
Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates
NCT06737003 ·Status: COMPLETED ·Phase: NA
-
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
NCT02340299 ·Status: TERMINATED ·Phase: NA
-
Integrated Prediction of Extubation Outcome by the Spontaneous Breathing Trial in Newborn Infants
NCT03956511 ·Status: COMPLETED
-
NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
NCT03099694 ·Status: COMPLETED ·Phase: NA
-
Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
NCT04821011 ·Status: COMPLETED
-
Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates
NCT03133663 ·Status: COMPLETED ·Phase: NA
-
Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates
NCT03551314 ·Status: COMPLETED ·Phase: NA
-
Optimising HFO&VTV in Newborn Infants
NCT06719284 ·Status: RECRUITING ·Phase: NA
-
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
NCT03298035 ·Status: COMPLETED ·Phase: NA
-
Pressure Sensitive Mats for Patient Monitoring in the NICU
NCT03224286 ·Status: COMPLETED
-
Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms
NCT02396693 ·Status: COMPLETED ·Phase: NA
-
Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
NCT02967549 ·Status: COMPLETED ·Phase: NA
-
HFNC and NCPAP in Extremely Preterm Infants
NCT03649282 ·Status: COMPLETED ·Phase: NA
-
Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
NCT03159039 ·Status: COMPLETED ·Phase: NA
-
Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
NCT04118400 ·Status: UNKNOWN
-
Non-invasive Intervention for Apnea of Prematurity
NCT02641249 ·Status: COMPLETED ·Phase: NA
-
Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
NCT03711565 ·Status: WITHDRAWN ·Phase: NA