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Vaccine
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Atlanta, GA
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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will compare the safety of 2-month childhood vaccines in preterm infants.
See full description
Eligible Conditions
- Home Sleep Apnea Test
- Apnea
- Neonatal Apnea
- Premature Infants
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~4990
PCV13
2017
Completed Phase 4
~8440
DTaP
2019
Completed Phase 4
~10610
HBV
2009
Completed Phase 4
~760
Hib
2018
Completed Phase 4
~5920
Find a Location
Closest Location:Cincinnati Children's Hospital Medical Center· Cincinnati, OH· 97 miles
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,494 Previous Clinical Trials
5,908,783 Total Patients Enrolled
Centers for Disease Control and PreventionFED
896 Previous Clinical Trials
25,010,854 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
841 Previous Clinical Trials
6,564,699 Total Patients Enrolled
University of North CarolinaOTHER
173 Previous Clinical Trials
1,456,549 Total Patients Enrolled
Karen Broder, MDPrincipal InvestigatorCenters for Disease Control and Prevention
5 Previous Clinical Trials
1,040 Total Patients Enrolled
Patricia Wodi, MDPrincipal InvestigatorCenters for Disease Control and Prevention
Rachel G Greenberg, MDPrincipal InvestigatorDuke University
Andrea Trembath, MDPrincipal InvestigatorUniversity of North Carolina
Mary A Staat, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati