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

NCT02095041 | Completed

• 1 other identifier: TOST
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Oxygen saturation.; Term infants.; Saturation trend.; Histogram.; Public health nurse.; congenital heart disease screening.

Outcome Measures

Primary Outcomes (1)

• Measurement of Normal oxygen saturation values and their variability in the newborn period

  Measurement of oxygen saturations on healthy newborns repeatedly and for extended periods. This will allow the investigators to describe both the variability in oxygen saturations and the pattern of changes observed in oxygen saturations over time in healthy newborns. To understand that babies included in the study were healthy at birth, they will be followed for 8 weeks to identify indicators of perinatal disease that was missed clinically.

  8 weeks

Secondary Outcomes (1)

• Analysis of Oxygen saturation profiles of infants needing hospital readmission or emergency department visits.

  8 weeks

Study Arms (1)

Healthy Term infants

Eligibility Criteria

• Age: 6 Hours - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Helathy Term infants in the post partum unit .

You may qualify if:

• newborns ≥37 weeks gestation at birth
• age between 6 to 24 hours at time of enrolment
• admission to level 1 ("normal") nursery
• inborn at one of the three study sites
• the family resides within the catchment area of the Public Health Nurse program
• Normal cardio-respiratory examination (as defined by ACORN)

You may not qualify if:

• \. antenatal or postnatal diagnosis of congenital heart disease 2. pulmonary disease 3. Blood dyscrasia. 4. other major congenital abnormality 5. at risk for neonatal abstinence syndrome 6. Admission to neonatal intensive care unit or pediatric intensive care unit.

Sponsors & Collaborators

• University of Calgary: lead
• The Sandra Schmirler Foundation: Advancing Neonatal Critical Care Fellowship Grant.: collaborator

Study Sites (4)

Peter Lougheed Hospital

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Medical center, Room C211, 1403 - 29th Street NW

Calgary, Alberta, T2N 2T9, Canada

Location

Alberta health services-south port public health calgary

Calgary, Alberta, T2W 3N2, Canada

Location

Rockyview General Hospital

Calgary, Alberta, Canada

Location

Related Publications (1)

• Kannan Loganathan P, Nettel-Aguirre A, Lodha A, Al Awad E, Fajardo C, Nair V, Scotland J, Singhal N, Young M, York K, Rabi Y. Oxygen saturation in healthy-term neonates at high altitude: A multisite prospective study. Paediatr Child Health. 2023 Nov 24;29(7):422-428. doi: 10.1093/pch/pxad072. eCollection 2024 Nov.

  PMID: 39677394 DERIVED

Study Officials

• Prakash Loganathan, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: February 22, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2015
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CA (4)