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Trends In Oxygen Saturation In Healthy Term Infants In The First Few Days Of Life: The "TOST" Study

NCT02095041 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 293

Last updated 2021-04-01

No results posted yet for this study

Summary

Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a measure of how much oxygen hemoglobin is carrying as a percentage of the maximum it could carry. Oxygen saturation can be measured non-invasively using pulse oximetry. On occasion, term infants are admitted to the intensive care nursery for monitoring and show variability in their oxygen saturation despite appearing well. As healthy newborns do not undergo routine monitoring of oxygen saturation, health care team do not know the degree to which variability in oxygen saturation are a normal phenomenon. With increasing interest in using pulse oximetry as a screening tool to identify "at risk" newborns, it is important to have a clear understanding of postnatal oxygen saturation trends and their variability in healthy babies.

In our study, Investigators will measure oxygen saturation on healthy newborns repeatedly and for extended periods. This will allow us to describe both the variability in oxygen saturations and the pattern of changes observed in oxygen saturations over time in healthy newborns. To increase our confidence that babies included in our study were healthy at birth, they will be followed for 8 weeks to identify indicators of perinatal disease that was missed clinically. Any babies subsequently identified as having significant disease will be analyzed separately from the main cohort of healthy babies. Furthermore, the oxygen saturation readings will be obscured so as not to influence caregivers inappropriately. Lastly, pulse oximetry measurements will be performed after discharge from hospital (on day 3 to 4), potentially increasing the clinical utility of this study as it has repeatedly been stated in the literature that the sensitivity of pulse oximetry to detect important underlying disease increases significantly if performed several days after birth. This study will provide important and novel normative data.

Conditions

  • Normative Oxygen Saturation Data Will Help us in
  • Discharge Planning
  • Describing Guidelines for Pulse Oximetry Screening
  • Identification of High Risk Infants

Sponsors & Collaborators

  • The Sandra Schmirler Foundation: Advancing Neonatal Critical Care Fellowship Grant.

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Prakash Loganathan, MD · University of Calgary

Eligibility

Min Age
6 Hours
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-06-30
Completion
2015-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095041 on ClinicalTrials.gov