Oxygen Saturation and Caffeine Post-Discharge

NCT ID: NCT02386046

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-10-31

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.

Conditions

Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Reference Group

Late preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age.

Pulse oxymeter measurements

Intervention Type: OTHER

Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

Study Group

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.

Pulse oxymeter measurements

Intervention Type: OTHER

Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

Control Group

Infants born 26-35 weeks not requiring caffeine. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age.

Pulse oxymeter measurements

Intervention Type: OTHER

Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

Interventions

Pulse oxymeter measurements

Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Gestational age at birth of < or = 35 weeks

2. Families of infants that live in Calgary

3. Infants discharged home from PLC or South Health Campus (SHC)

4. Decision of treating team to start caffeine

5. No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge

6. Infant has access to reliable post-discharge follow up

Exclusion Criteria

1. Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).

2. Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 46 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Carlos Fajardo

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos A Fajardo, Md

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Veronica Samedi, Md

Role: STUDY_DIRECTOR

Alberta Health services

Locations

Peter Logheed Center

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB14-0175

Identifier Type: -

Identifier Source: org_study_id