Oxygen Saturation and Caffeine Post-Discharge (OCPDPS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Prematurity
• Intervention / Treatment: Other: Pulse oxymeter measurements

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Logheed Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 10 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborn infants admitted at two NICU centers in Calgary born prematurely between 26 weeks and 34 weeks of gestational age.

Newborn infants admitted directly to the normal nursery in those two centers born less than 38 weeks.

Description

Inclusion Criteria of infants admitted to NICU:

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 of all infants:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Reference Group; Late preterm infants without any pathology. Intervention: Pulse oxymeter measurements at the hospital and weekly thereafter until 46 weeks postconceptional age.	Other: Pulse oxymeter measurements; 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.	Other: Pulse oxymeter measurements; 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.	Other: Pulse oxymeter measurements; Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of Oxygen saturation	Measurements at hospital and weekly after discharge	Up to 46 weeks postconceptional age

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Carlos A Fajardo, Md, University of Calgary; Study Director: Veronica Samedi, Md, Alberta Health Services

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Normative data; Caffeine use
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: REB14-0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED