Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
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 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.
Inclusion Criteria:

 1. ≤32 weeks gestational age at birth

 2. ≥6 weeks postnatal age at randomization

 3. Remains hospitalized after birth (has never been discharged home)

 4. Treating clinician deems infant eligible to receive 2-month vaccines

 5. English- or Spanish-speaking parent(s)/legally authorized representative(s) (LAR(s))

 6. Not planned for discharge within 60 hours of study entry

 7. The parent/guardian must be willing and capable of providing permission for their
 child to participate through the written informed consent process

 Exclusion Criteria:

 1. Receipt of DTaP, IPV, PCV13, or Hib prior to enrollment. Previous administration of
 the first dose of HBV is permitted

 2. Anticipated receipt of any vaccine other than DTaP, IPV, HBV, PCV13, or Hib during the
 first 60 hours after randomization

 3. History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any
 hepatitis B vaccine

 4. History of a severe allergic reaction (e.g. anaphylaxis) to any component of the
 vaccines used in the study including neomycin, yeast and polymyxin B

 5. History of latex allergy

 6. Fever ≥38°C within 48 hours prior to randomization*

 *This may result in a temporary delay of randomization

 7. Active known respiratory infection within 48 hours prior to randomization*

 *This may result in a temporary delay of randomization

 8. Active infection being treated with systemic antimicrobials*

 *This may result in a temporary delay of randomization

 9. Requiring mechanical ventilation or support with nasal intermittent positive pressure
 ventilation (NIPPV)*

 *This may result in a temporary delay of randomization

 10. History of unstable progressive neurologic disorder of unknown cause

 11. Known cause of apnea other than apnea of prematurity

 12. Cyanotic heart disease (congenital or acquired)

 13. Major invasive medical or surgical procedure (including circumcision) within 48 hours
 prior to randomization or anticipated to have major invasive medical or surgical
 procedure during the first 60 hours after randomization*

 *This may result in a temporary delay of randomization

 14. Child or parent/LAR is an immediate relative of study staff or an employee who is
 supervised by study staff.

 15. Any condition that would, in the opinion of the site investigator, place the
 participant at an unacceptable risk of injury or render the participant unable to meet
 the requirements of the protocol