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Clinical Trials/NCT02386046
NCT02386046TerminatedNot Applicable

Does the Use of Caffeine Post Discharge Normalize the Respiratory Patterns in Infants Born Earlier Than 35 Weeks? A Cohort Study

University of Calgary1 site in 1 country144 target enrollmentStarted: February 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
144
Locations
1
Primary Endpoint
Pattern of Oxygen saturation

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
26 Weeks to 46 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pattern of Oxygen saturation

Time Frame: Up to 46 weeks postconceptional age

Measurements at hospital and weekly after discharge

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carlos Fajardo

Clinical Associate Professor

University of Calgary

Study Sites (1)

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