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Comparison of two methods of applying the pulse oximeter device for assessing oxygen status in newborn babies immediately after birth

Comparison of two different methods of pulse oximeter probe application during neonatal resuscitation: an open label randomized controlled trial - PONDER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/05/003631
Enrollment
150
Registered
2013-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- neonates in delivery room

Interventions

Intervention1: sensor to infant first: Intervention 1: Pulse oximeter kept switched on
extension cable attached to oximeter
sensor applied first to infant followed by to extension cable or Control Intervention1: pulse oximeter probe application using two methods: time to reliable saturation Control Intervention2: sensor t
sensor connected to cable and then applied to infant

Sponsors

PGI new institute research scheme
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All liveborn infants >=28 weeks gestational age born between 9am and 5pm during the trial period were consecutively enrolled.

Exclusion criteria

Exclusion criteria: Neonates with antenatally diagnosed or suspected major malformations of the lungs or airways, hydrops or skin edema, those born after precipitous deliveries where time for informed consent was not available were excluded

Design outcomes

Primary

MeasureTime frame
Primary outcome was the time taken from completion of sensor application to the appearance of first reliable display of pulse saturation and heart rate on the pulse oximeterTimepoint: Primary outcome was the time taken from completion of sensor application to the appearance of first reliable display of pulse saturation and heart rate on the pulse oximeter

Secondary

MeasureTime frame
Secondary outcomes measured included time from birth to start of sensor application (the point when the patient sensor touched the neonatesâ?? hand was considered as the start of sensor application), time taken for sensor application, total time taken from birth to appearance of first reliable signal, proportion of infants where a reliable data could not be recorded and proportion of infants where the sensor had to reapplied due to lack of signal.Timepoint: Immediately after birth

Countries

India

Contacts

Public Contactpraveen kumar

PGIMER

venkatpgi@gmail.com01722755340

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026