NCT03530124

Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines

A Prospective, Randomized, Open-label Clinical Trial to Assess Apnea Following Administration of 13-valent Conjugate Pneumococcal Vaccine, Diphtheria Toxoid, Tetanus Toxoid, and Acellular Pertussis Vaccine, Inactivated Polio Vaccine, Hepatitis B Vaccine, and Haemophilus Influenzae Type B Vaccine in Preterm Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Modified Intent-to-Treat (mITT) Analysis Population: Defined as any infant that was enrolled and randomized in the study For the mITT analysis, infants will be analyzed in their assigned treatment arms irrespective of receipt of vaccine. Study outcomes will be included in the analysis as follows: i) Vaccinated group: study outcomes in the 48-hour monitoring after vaccination. If vaccination does not occur by 12 hours after randomization, then study outcomes will be assessed between 12 and 60 hours after randomization. ii) Unvaccinated group: study outcomes in the 48-hour monitoring period after randomization.

Conditions

• Apnea
• Apnea Neonatal
• Prematurity

Interventions

Type	Name	Description
BIOLOGICAL	PCV13	Advisory Committee on Immunization Practices (ACIP) Recommended vaccine
BIOLOGICAL	DTaP	ACIP Recommended vaccine
BIOLOGICAL	HBV	ACIP Recommended vaccine
BIOLOGICAL	IPV	ACIP Recommended vaccine
BIOLOGICAL	Hib	ACIP Recommended vaccine

Timeline

• Start date: 2018-07-17
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2018-05-21
• Last updated: 2024-02-14
• Results posted: 2023-01-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study