Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Duke University.
NCT03530124 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 223 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of infants with ≥ 1 apneic event in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group, mITT Population Apnea was defined as a pause in respirations of \>20 seconds, or a pause in respirations of \>15 seconds with associated bradycardia (heart rate \<80 beats per minute for any duration occurring within 1 minute of the apnea event). Potential apnea events triggered by the cardiorespirator
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 |
What the finished NCT03530124 record still lists
NCT03530124 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Hib is the first listed.
NCT03530124 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03530124's enrollment target sits among peer trials
223 383rd of 2000 higher than 1,618 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06640803 · 223 participants · NA
Sacramento Clinical High Risk for Psychosis Stepped-Care Program
- NCT07175285 · 223 participants
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
- NCT07205718 · 223 participants · Phase 1
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
- NCT02706561 · 224 participants · NA
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI