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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16473881

Enrollment

100

Registered

2018-07-19

Start date

2018-08-01

Completion date

Unknown

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery room care of preterm infants Pregnancy and Childbirth Delivery room care of preterm infants

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Major congenital anomalies

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026