Comparing different monitors for high-risk babies in the delivery room

ISRCTN	ISRCTN16473881
DOI	https://doi.org/10.1186/ISRCTN16473881
Protocol serial number	SHEEP2
Sponsor	National Maternity Hospital
Funder	National children's Research Centre provide salary support for Madeleine Murphy

Submission date: 17/07/2018
Registration date: 19/07/2018
Last edited: 18/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Colm O'Donnell
Scientific

Neonatal Unit, National Maternity Hospital, Holles Street
Dublin
D02 YH21
Ireland

Phone	+353 1 6373100
Email	codonnell@nmh.ie

Study information

Primary study design	Interventional
Study design	Interventional single-centre, unmasked, randomised parallel group study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
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
Study acronym	SHEEP2
Study objectives	Electrocardiogram (ECG) and pulse oximetry gives a heart rate (HR) more quickly than pulse oximetry alone in the first minutes of life.
Ethics approval(s)	National Maternity Hospital, Dublin, Ireland, 13/03/2018, EC 05.2018
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Time (seconds) to first heart rate from monitor application, measured with a stopwatch from a video recording within 30 minutes of birth
Key secondary outcome measure(s)	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
Completion date	31/10/2019

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	100
Total final enrolment	39
Key inclusion criteria	1. Infant 2. Born between 29 and 35 weeks of gestation
Key exclusion criteria	Major congenital anomalies
Date of first enrolment	01/08/2018
Date of final enrolment	30/07/2019

Locations

Countries of recruitment

Ireland

Study participating centre

National Maternity Hospital

Holles Street, Dublin 2
Dublin
D02 YH21
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2021	18/01/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.