Does sleeping position affect the amount of change in heart rate in newborn babies?
| ISRCTN | ISRCTN11702082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11702082 |
| EudraCT/CTIS number | 2020-000701-88 |
- Submission date
- 08/03/2020
- Registration date
- 13/03/2020
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Klementa Juga 16
Solkan
5250
Slovenia
 ORCID ID |
0000-0001-7255-7201 |
|---|---|
| Phone | +38 (0)653301141 |
| matjaz.klemenc@bolnisnica-go.si |
Study information
| Study design | Cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet (klemenc.matjaz@gmail.com) |
| Scientific title | The effect of sleeping position on heart rate variability in newborns |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/09/2016 |
| Overall study end date | 01/09/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 46 |
| Participant inclusion criteria | 1. Stable cardiovascular and respiratory systems 2. No respiratory and/or hemodynamic support |
| 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
Study participating centre
Bohoričeva ulica 20
Ljubljana
1000
Slovenia
Sponsor information
Hospital/treatment centre
Neonatal Department of the Division of Paediatrics
Bohoričeva ulica 20
Ljubljana
1000
Slovenia
| Phone | +38 (0)65522 37 00 |
|---|---|
| petja_fister@yahoo.com | |
| Website | http://www.kclj.si/ |
"ROR" |
https://ror.org/01nr6fy72 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 10/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results expected to be published in BMC Pediatrics. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/04/2020 | 23/10/2020 | Yes | No |
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.
