Condition category
Pregnancy and Childbirth
Date applied
15/03/2017
Date assigned
04/05/2017
Last edited
15/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Immediately after birth, a baby's heart rate (HR) is measured to determine if babies need help with their breathing. This was traditionally done using a stethoscope. Over the last ten years, pulse oximeters have increasingly been used to measure HR after birth. Pulse oximeters (PO) are machines which non-invasively measure blood oxygen levels and HR. PO measures HR by counting the number of pulses in the hand. They have been used to monitor infants HR for many years. More recently, electrocardiograms (ECG) have been recommended to measure HR in newly born infants. This method uses sensors to measure HR. For either method, it is important that information is displayed quickly, especially right after birth when it is critical to know if a baby requires help breathing. The National Maternity Hospital (Ireland) current uses PO to measure and monitor HR of a baby right after birth. However, the hospital has machines that combine both ECG and PO that are being used in the neonatal unit (post birth unit). These could be used instead of PO to measure HR right after birth if they are able to quickly measure and monitor HR of babies. The aim of this study is to compare two different heart monitoring machines to see how quickly they are able to provide HR information.

Who can participate?
Babies born at the National Maternity Hospital (Ireland)

What does the study involve?
Newborn babies are randomly allocated to one of two groups. Those in the first group have their HR measured using a monitor that combines both an ECG and a PO. This involves an ECG sensor and a PO monitored placed around their right wrist or hand. Those in the second group have their HR measured only using a PO monitor that is placed around their right wrist or hand. The time taken for each monitor to display the babies HR is recorded and there is no further follow up involved for participants.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
National Maternity Hospital (Ireland)

When is the study starting and how long is it expected to run for?
February 2017 to June 2017

Who is funding the study?
National Maternity Hospital (Ireland)

Who is the main contact?
Professor Colm O’Donnell

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colm O'Donnell

ORCID ID

http://orcid.org/0000-0001-7453-5452

Contact details

Neonatal Unit
National Maternity Hospital
Holles Street
Dublin
D02 YH21
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SHEEP001

Study information

Scientific title

A randomised study of heart rate estimation comparing two monitors (electrocardiogram plus pulse oximeter versus pulse oximeter alone) in newly-born infants

Acronym

SHEEP

Study hypothesis

Electrocardiogram and pulse oximetry gives a heart rate (HR) more quickly than pulse oximetry alone in the first minutes of life.

Ethics approval

Research Ethic Committee at the National Maternity Hospital, 06/03/2017, ref: EC04.2017

Study design

Single-centre unmasked randomised parallel group study

Primary study design

Observational

Secondary study design

Randomised parallel group comparison

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Delivery room care of newborn infants

Intervention

Newly-born infants are transferred to an open resuscitation cot as practicable after birth. Infants are randomly allocated to one of two groups.

Intervention group: Infants are monitored using the Intellivue X2 monitor (Philips, Eindhoven, Netherlands) which incorporates electrocardiogram (ECG) and pulse oximetry (PO). The infants have the ECG applied before the PO sensor is placed around their right wrist or hand and attached to the machine.

Control group: Infants are monitored with a Nellcor PM1ON portable PO (Covidien, Boulder CO, USA). The PO sensor is placed around the right wrist or hand and then attached to the machine. Infants are observed to ensure that they are well as is standard with any birth.

The time taken for each monitor to display the infants heart rate (HR) is recorded and the infants participation in the study ends at this point and there is no further follow-up. The duration of participation is around five minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Time to first heart rate from monitor application measured in seconds using a stopwatch.

Secondary outcome measures

1. Failure of monitoring (i.e. heart is not displayed) is measured within 5 minutes of applying the monitor
2. Time taken to apply monitor is measured in seconds using a stopwatch
3. Skin damage with leads/sensors are measured by visual inspection at around five minutes

Overall trial start date

01/02/2017

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All infants (term and pre-term) born at National Maternity Hospital.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Major congenital anomalies
2. No antenatal consent

Recruitment start date

17/04/2017

Recruitment end date

15/06/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

National Maternity Hospital
Neonatal Unit Holles Street
Dublin
D02 YH21
Ireland

Sponsor information

Organisation

National Maternity Hospital

Sponsor details

Neonatal Unit
Holles Street
Dublin 2
Dublin
D02 YH21
Ireland

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

National Maternity Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication and dissemination plan as of 15/10/2018:
Submission of results for presentation at the annual meeting of the European Society for Paediatric Research and Pediatric Academic Societies.

IPD sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Previous publication and dissemination plan:
Submission of results for presentation at the annual meeting of the European Society for Paediatric Research and Pediatric Academic Societies.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/06/2018

Participant level data

Other

Basic results (scientific)

See additional file (ISRCTN11028739_BasicResults_15Oct18.pdf)

Publication list

Publication citations

Additional files

Editorial Notes

15/10/2018: The following updates were made: 1. The publication and dissemination plan was updated. 2. The participant level data was updated. 3. The basic results of this trial have been uploaded as an additional file.