Oxygen Saturation and Caffeine Post-Discharge

Terminated

• Conditions: Prematurity
• Interventions: Other: Pulse oxymeter measurements

• Registration Number: NCT02386046
• Lead Sponsor: University of Calgary

Brief Summary

This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it.

Detailed Description

Apnea of prematurity is a common morbidity among premature infants. Recent studies suggest an association between apnea and neurodevelopmental impairment. Our objectives are to determine normative values of oxygen saturation in late preterm infants -reference group. In infants born 28-35 weeks requiring caffeine- study group and infants born 28-35 weeks not requiring caffeine-control group we will be evaluating the frequency of hypoxic events. Recruitment time: February 2015 until December 2016.

After consent a pulse oxymeter will be placed on the infant's right wrist. For those infants that will receive caffeine prior to discharge, this medication will be instituted after 12 hours of the initiation of the study and continue for the remaining of the hospitalization. For all other infants, the pulse oxymeter will be done continuously until discharge. After discharge, the recording will be done at home once a week until 46 weeks corrected age in the three groups.

All the data will be reviewed by a blind observer to the groups from which that data comes. The data will be analyzed by a statistician.

Normative values will be developed on the reference group until 46 weeks post conceptional age.

Any medical problems encounter by the patients while on the study or in the following 6 months will be recorded to establish the safety of caffeine use at home and its discontinuation at 44 weeks post conceptional age.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Status Verified: 2017-05
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reference Group	Pulse oxymeter measurements	Late preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age.
Study Group	Pulse oxymeter measurements	Infants born 26-35 weeks requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital before and after caffeine instituted, and weekly thereafter until 46 weeks postconceptional age.
Control Group	Pulse oxymeter measurements	Infants born 26-35 weeks not requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age.

Primary Outcome Measures

Name	Time	Method
Pattern of Oxygen saturation	Up to 46 weeks postconceptional age	Measurements at hospital and weekly after discharge

Trial Locations

Locations (1)

Peter Logheed Center; 🇨🇦 Calgary, Alberta, Canada