Condition category
Circulatory System
Date applied
08/03/2020
Date assigned
13/03/2020
Last edited
23/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Heart rate variability reflects the responsiveness of the autonomic nervous system to environmental factors. In a stressful environment, the sympathetic nervous system dominates, reducing the heart rate variability. Lower heart rate variability is a risk factor for unfavorable outcomes of various diseases, a longer recovery, and sudden heart death in newborns. The aim of this study is to determine whether a newborn’s sleeping position affects their heart rate variability.

Who can participate?
Healthy newborns aged 1 to 28 days after birth

What does the study involve?
While the newborns sleep, the researchers measure heart rate variability in four sleeping positions, namely supine without and with tilt, and prone with and without tilt. At the same time they measure blood oxygen levels, heart and breathing rates, blood pressure and body temperature, and assess alertness.

What are the possible benefits and risks of participating?
The benefit of participating is the analysis of the newborn’s heart rhythm. If there are heart rhythm problems the researchers consult a pediatric cardiologist. There are no risks of participating.

Where is the study run from?
University Medical Centre Ljubljana (Slovenia)

When is the study starting and how long is it expected to run for?
September 2016 to September 2018

Who is funding the study?
University Medical Centre Ljubljana (Slovenia)

Who is the main contact?
Prof. Matjaž Klemenc
matjaz.klemenc@bolnisnica-go.si

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matjaž Klemenc

ORCID ID

http://orcid.org/0000-0001-7255-7201

Contact details

Klementa Juga 16
Solkan
5250
Slovenia
+38 (0)653301141
matjaz.klemenc@bolnisnica-go.si

Additional identifiers

EudraCT number

2020-000701-88

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The effect of sleeping position on heart rate variability in newborns

Acronym

Study hypothesis

It is hypothesized that the parameters of heart rate variability might be more favorable for outcome in the supine position compared to prone, even more so with tilt.

Ethics approval

Approved 20/09/2016, National Ethics Committee of Slovenia (Štefanova ulica 5, 1000 Ljubljana, Slovenia; +386 (0)1 478 60 01; gp.mz@gov.si), ref: 0120-458/2016-3 KME 67/09/16

Study design

Cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet (klemenc.matjaz@gmail.com)

Condition

Cardiovascular and respiratory stable newborns who had no respiratory and/or haemodynamic support

Intervention

After feeding, sleeping newborns were placed in a supine position with a 30˚head-up tilt of the bed for 30 min. ECG signals were recorded in four positions: the supine without and with tilt and prone with and without tilt by using an ECG Holter system (Vision 5L, Burdick, USA). Parameters were recorded in every position for at least 30 minutes, when the newborn was sleeping quietly. Simultaneously, the newborn’s alertness was assessed using a five-stage description. In all positions, the breathing frequency (BF) was counted (by visualizing the excursions of the thorax) and heart rate (HR) and blood oxygenation were measured by pulse oximeter (Intelli Vue MP 50, Philips, Germany) 10 min after changing the lying position of the newborn. Blood pressure (systolic and diastolic) was measured noninvasively using an inflatable cuff. Body temperature was measured by infrared non-contact frontal thermometer Veratemp + (Veratemp; USA).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Heart rate variability (HRV) measured by pulse oximeter for at least 30 minutes when the newborn was sleeping quietly in four positions

Secondary outcome measures

Parameters recorded in every position for at least 30 minutes, when the newborn was sleeping quietly:
1. Blood oxygenation measured using a pulse oximeter
2. Breathing frequency (BF) counted by visualizing the excursions of the thorax
3. Mean arterial blood pressure (MAP) measured using an inflatable cuff

Overall trial start date

01/09/2016

Overall trial end date

01/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Stable cardiovascular and respiratory systems
2. No respiratory and/or hemodynamic support

Participant type

Healthy volunteer

Age group

Neonate

Gender

Both

Target number of participants

50

Total final enrolment

46

Participant exclusion criteria

1. Hypoxic ischemic encephalopathy (HIE)
2. Preterm birth
3. Infection
4. Neurological or congenital abnormalities

Recruitment start date

17/11/2017

Recruitment end date

31/07/2018

Locations

Countries of recruitment

Slovenia

Trial participating centre

University Medical Centre Ljubljana
Neonatal Department of the Division of Paediatrics Bohoričeva ulica 20
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Ljubljana University Medical Centre

Sponsor details

Neonatal Department of the Division of Paediatrics
Bohoričeva ulica 20
Ljubljana
1000
Slovenia
+38 (0)65522 37 00
petja_fister@yahoo.com

Sponsor type

Hospital/treatment centre

Website

http://www.kclj.si/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Ljubljana

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results expected to be published in BMC Pediatrics.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Matjaž Klemenc (klemenc.matjaz@gmail.com). Raw data (ECG recordings) will become available from 01/05/2020 for the next 5 years. Access criteria: research in the field of heart rate variability in neonates, statistical analyses, data are anonymised, no ethical or legal restrictions.

Intention to publish date

10/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32284055/ (added 23/10/2020)

Publication citations

Additional files

Editorial Notes

23/10/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 13/03/2020: Trial's existence confirmed by National Ethics Committee of Slovenia.