Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Condition: Apnea; Apnea Neonatal; Prematurity
MeSH terms: Apnea
Intervention: PCV13; DTaP; HBV; IPV; Hib
Intervention description: Advisory Committee on Immunization Practices (ACIP) Recommended vaccine; ACIP Recommended vaccine; ACIP Recommended vaccine; ACIP Recommended vaccine; ACIP Recommended vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 6 Weeks
Healthy volunteers: No
Keywords: apnea following vaccination

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. <33 and 0 days weeks gestational age at birth

          2. ≥6 weeks and 0 days and ≤12 weeks and 0 days 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