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NCT03530124 · ClinicalTrials.gov registry record · Phase 4
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 223
- Enrollment target
NCT03530124 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 223 participants.
The verdict
NCT03530124, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 223 participants
- Enrollment target
Study Summary
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North Carolina, and Cincinnati Children's Hospital Medical Center. Eligible infants will be randomized 1:1 to receive either 2-month US licensed childhood vaccines (PCV13, DTaP, HBV, IPV an Hib) or no vaccines. After their participation in the study, healthcare providers of the infants in the unvaccinated group will make decision abut receipt of their 2-month childhood vaccines. The study will collect data from the continuous cardiorespiratory and pulse oximetry monitors from randomization to 48 hours after randomization for infants in the unvaccinated group, and from randomization to 48 hours after vaccination for infants in the vaccinated group. Infants in both groups will be monitored for up to 60 hours for the occurrence of apnea, bradycardia, and oxygen desaturation. For infants in the "vaccinated" group, the study will also collect adverse events of clinical interest and serious adverse events occurring between the end of the 48-hour monitoring period and 14 days after vaccination. This information will be collected through parental report and review of medical records.
Interventions
- BIOLOGICAL Hib
- BIOLOGICAL PCV13
- BIOLOGICAL DTaP
- BIOLOGICAL HBV
- BIOLOGICAL IPV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03530124
The ClinicalTrials.gov registry entry for NCT03530124 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Hib is the first listed.
NCT03530124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03530124 about?
NCT03530124 is a clinical study titled "Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines". A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North Carolina, and Cincinnati Children's Hospital Medical Center. Eligible i...
What is the current status of trial NCT03530124?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 223 participants. The study started on 2018-07-17. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT03530124?
The interventions under investigation include: Hib (BIOLOGICAL), PCV13 (BIOLOGICAL), DTaP (BIOLOGICAL), HBV (BIOLOGICAL), IPV (BIOLOGICAL).
Who is sponsoring clinical trial NCT03530124?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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