Heart Rate Variability of Premature Newborn (HRV)

January 11, 2024 updated by: Letícia de Queiroz Martins, Federal University of Uberlandia

Heart Rate Variability of Premature Newborn Subject to Two CPAP Methods

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Adriano de Oliveira Andrade, 3
  • Phone Number: 55 (34) 3239-4709
  • Email: adriano@ufu.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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.
Active Comparator: CPAP Group
The analysis of heart rate variability will be carried out in the in the CPAP group, conventional and in the bubble CPAP.
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.

Other Names:
  • continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRV variables in time domains
Time Frame: 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 (%).
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
Time Frame: 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.
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
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Collaborators

Adriano de Oliveira Andrade

Investigators

  • Study Chair: Lilian Rodrigues de Abreu Macedo, 3, Federal University of Uberlândia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Federal University Uberlandia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autonomic Nervous System Imbalance

Clinical Trials on CPAP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe