Oxygen Saturation and Caffeine Post-Discharge

NCT02386046 | Terminated

• 1 other identifier: REB14-0175
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

Caffeine use; Normative data

Outcome Measures

Primary Outcomes (1)

• Pattern of Oxygen saturation

  Measurements at hospital and weekly after discharge

  Up to 46 weeks postconceptional age

Study Arms (3)

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

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

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

Interventions

Pulse oxymeter measurements OTHER

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

Control Group; Reference Group; Study Group

Eligibility Criteria

• Age: 26 Weeks - 46 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Gestational age at birth of \< or = 35 weeks
• Families of infants that live in Calgary
• Infants discharged home from PLC or South Health Campus (SHC)
• Decision of treating team to start caffeine
• No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge
• Infant has access to reliable post-discharge follow up

You may not qualify if:

• Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).
• Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Peter Logheed Center

Calgary, Alberta, T1Y 6J4, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Carlos A Fajardo, Md

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Veronica Samedi, Md

  Alberta Health services

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: February 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: April 17, 2019

Record last verified: 2017-05

Locations

CA (1)