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Vaccine

Vaccinated for Sleep Apnea

Phase 4
Waitlist Available
Led By Karen Broder, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Summary

This trial will compare the safety of 2-month childhood vaccines in preterm infants.

Eligible Conditions
  • Sleep Apnea
  • Neonatal Apnea
  • Premature Infants

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of Apnea
Secondary study objectives
Duration of Apneic Episodes
Increase in Respiratory Support
Number of Apneic Episodes
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VaccinatedExperimental Treatment5 Interventions
In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
Group II: UnvaccinatedActive Control1 Intervention
In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPV
2016
Completed Phase 4
~4590
PCV13
2017
Completed Phase 4
~6340
DTaP
2019
Completed Phase 4
~10610
HBV
2009
Completed Phase 4
~760
Hib
2018
Completed Phase 4
~5920

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,861 Total Patients Enrolled
Centers for Disease Control and PreventionFED
882 Previous Clinical Trials
22,474,762 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
827 Previous Clinical Trials
6,564,224 Total Patients Enrolled
2 Trials studying Sleep Apnea
49 Patients Enrolled for Sleep Apnea
~31 spots leftby Sep 2025
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