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

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.

Conditions

• Apnea
• Apnea Neonatal
• Prematurity

Interventions

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Rachel G Greenberg, MD · Duke University

• Andrea Trembath, MD · University of North Carolina

• Mary A Staat, MD · Children's Hospital Medical Center, Cincinnati

• Karen Broder, MD · Centers for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-17

Primary Completion

2021-11-01

Completion

2021-11-01

FDA Drug

Yes

Countries

• United States

Study Locations