Condition category
Pregnancy and Childbirth
Date applied
17/07/2018
Date assigned
19/07/2018
Last edited
19/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
All newborn babies are assessed soon after birth. The heart rate is measured to see if they need help with their breathing. This may be done done by listening to the heart with a stethoscope. However, newborn babies often have their heart rate measured in other ways. Electrocardiogram (ECG) is routinely used to measure a baby’s heart rate in the neonatal unit, by counting electrical impulses using stickers placed on the chest. Pulse oximeters may also be used to measure heart rate. While these machines are usually used to measure blood oxygen levels in the neonatal unit using a sensor that is placed around the hand, they also measure the heart rate by counting pulsations.
When the heart rate is measured immediately after birth, it is important that information is available quickly. For years we have measured the heart rate by listening with a stethoscope or using a pulse oximeter. More recently, ECG has been recommended to measure heart rate immediately after birth. However, we use machines that combine both ECG and pulse oximetry in the neonatal unit. This study aims to compare two different heart monitoring machines, one combining ECG and pulse oximetry, and the other using only pulse oximetry, to see how quickly they provide heart rate information after birth.

Who can participate?
Newly-born babies of both genders who are born between 29 and 35 weeks of gestation

What does the study involve?
Babies will be randomly assigned to one of two groups - the intervention or the control group. In the intervention group, babies will have their heart rate measured using a monitor that combines both ECG and a pulse oximeter. Those in the control group have their heart rate measured only using a pulse oximeter. The time taken for each monitor to display the heart rate is recorded and there is no further follow up involved for participants.

What are the possible benefits and risks of participating?
The possible benefit of taking part is that babies in this study may have their heart rate determined more quickly after birth. There are no known risks to participants taking part in this study.

Where is the study run from?
National Maternity Hospital, Dublin, Ireland

When is the study starting and how long is it expected to run for?
December 2017 to October 2019

Who is funding the study?
National Children's Research Centre, Dublin (Northern Ireland)

Who is the main contact?
Prof. Colm O’Donnell
codonnell@nmh.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colm O'Donnell

ORCID ID

Contact details

Neonatal Unit
National Maternity Hospital
Holles Street
Dublin
D02 YH21
Ireland
+353 1 6373100
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SHEEP2

Study information

Scientific title

Study comparing Heart rate Estimation using Electrocardiogram in addition to pulse oximetry versus Pulse oximetry alone in high-risk infants at birth: SHEEP2

Acronym

SHEEP2

Study hypothesis

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

Ethics approval

National Maternity Hospital, Dublin, Ireland, 13/03/2018, EC 05.2018

Study design

Interventional single-centre, unmasked, randomised parallel group study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

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

Condition

Delivery room care of preterm infants

Intervention

Infants will be randomly assigned in a 1:1 ratio into the intervention or the control group. The groups assignment schedule will be stratified by gestational age (29 – 31⁺⁶, 32 – 34⁺⁶) and generated in blocks of 4 using a random number table. The schedule will be kept concealed from investigators and clinicians attending the deliveries to care for the infants. Groups assignment will be written on cards that are contained in sequentially numbered sealed opaque envelopes. An envelope from the appropriate stratum will be opened shortly before delivery.
Infants in the intervention group will be monitored with the IntelliVue X2 (Philips, Eindhoven, Netherlands), a machine that combines ECG and pulse oximeter.
Infants in the control group will be monitored with a pulse oximeter (Nellcor, Covidien, Boulder CO, USA) alone
Infants will be monitored using the randomly assigned monitor in the delivery room. The majority of data will be collected in the delivery room, the last data point (temperature) will be acquired on admission to the neonatal unit. This time point will be variable for enrolled infants, but will be within 30 minutes of birth in the majority.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Time (seconds) to first heart rate from monitor application, measured with a stopwatch from a video recording within 30 minutes of birth

Secondary outcome measures

1. Time (seconds) from birth to first heart rate display by monitor, measured with a stopwatch from video recording
2. Time (seconds) taken to apply monitor, measured with a stop watch from video recording
3. Failure of monitor to display heart rate within 5 minutes of birth, determined from video recording
4. Reapplication of monitor, determined from video recording
5. Initial bradycardia (heart rate < 100 beats per minute) on pulse oximetry, determined from video recording
6. Intermittent pulse oximetry readings, determined from video recording
7. Number of handling events, determined from video recording
8. Duration (seconds) of handling events, measured with a stopwatch from video recording
9. Use of mask respiratory support, determined from video recording
10. Time (seconds) to mask respiratory support, measured with a stopwatch from video recording
11. Use of chest compressions, determined from video recording
12. Time (seconds) to chest compressions, measured with a stopwatch from video recording
13. Endotracheal intubation, determined from video recording
14. Time (seconds) to endotracheal intubation, measured with a stopwatch from video recording
15. Infants temperature (°C), measured with a digital thermometer on admission to neonatal unit

Overall trial start date

01/12/2017

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Infant
2. Born between 29 and 35 weeks of gestation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

100

Participant exclusion criteria

Major congenital anomalies

Recruitment start date

01/08/2018

Recruitment end date

30/07/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

National Maternity Hospital
Holles Street, Dublin 2
Dublin
D02 YH21
Ireland

Sponsor information

Organisation

National Maternity Hospital

Sponsor details

Holles Street
Dublin 2
Dublin
D02 YH21
Ireland
+353 1 6373100
codonnell@nmh.ie

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

National children's Research Centre provide salary support for Madeleine Murphy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will present the findings of our study at local and international scientific conferences, and submit them for publication in a peer-reviewed scientific journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as ethical approval to do so has not been sought.

Intention to publish date

31/07/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes