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Umbilical oximetry during the neonatal transition: a feasibility study

Umbilical oximetry during the neonatal transition: a feasibility study - PULSE study (Placing UmbiLical Sensor Early at birth study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48518
Enrollment
15
Registered
2019-11-27
Start date
2019-12-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

fysiologische neonatale transitie neonatal changes from intrauterine to extrauterine life neonatal transition

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Healthy infants born at Leiden University Medical Centre birth centre. Gestational age of at least 37 weeks, of multiparous mothers No need for resuscitation/respiratory support

Exclusion criteria

Exclusion criteria: significant congenital malformations influencing the cardiopulmonary transition signs of placental abruption or placenta praevia signs of severe fetal distress necessitating an emergency caesarean section infants needing respiratory support during transition as the cord will then be clamped immediately infants born via caesarean section infants with short umbilical cords, that are unable to be placed at their mothers chest

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the proportion of infants who have a reliable umbilical pulse oximetry signal acquisition within the first 60 seconds after birth

Secondary

MeasureTime frame
Proportion of infants in whom the umbilical cord oximeter can be successfully placed Time from birth to sensor application Time from sensor application to reliable signal acquisition Time from birth to reliable signal acquisition SpO2 (umbilical) at 2 second intervals during the first 10 min after birth HR (umbilical) at 2 second intervals during the first 10 min after birth Number of adverse events related to the umbilical cord

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)