Heart Rate Variability of Premature Newborn

NCT06217133 | Unknown

• 1 other identifier: Federal University Uberlandia
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autonomic Nervous System Imbalance

Keywords

Heart rate variability; Neonatal intensive care unit; Non-invasive ventilation

Outcome Measures

Primary Outcomes (3)

• HRV variables in time domains

  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 (%).

  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

• Frequency domain variables

  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.

  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 non-linear parameters of heart rate variability

  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.

  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

Study Arms (2)

control group

NO INTERVENTION

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

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

Device: CPAP

Interventions

CPAP DEVICE

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.

Also known as: continuous positive airway pressure

CPAP Group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Adriano de Oliveira Andrade: collaborator

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lilian Rodrigues de Abreu Macedo, 3

  Federal University of Uberlandia

  STUDY CHAIR

Central Study Contacts

Letícia de Queiroz Martins, 3

CONTACT

55 (34) 32182112; leticiaqm.fisio@hotmail.com

Adriano de Oliveira Andrade, 3

CONTACT

55 (34) 3239-4709; adriano@ufu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Letícia de Queiroz Martins

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 22, 2024
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01