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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03530124
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), Children's Hospital Medical Center, Cincinnati (Other), University of North Carolina (Other)
224
Enrollment
4
Locations
2
Arms
39.5
Actual Duration (Months)
56
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PCV13
  • Biological: DTaP
  • Biological: HBV
  • Biological: IPV
  • Biological: Hib
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Actual Study Start Date :
Jul 17, 2018
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Vaccinated

In the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from randomization to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.

Biological: PCV13
ACIP Recommended vaccine
Other Names:
  • 13-valent Conjugate Pneumococcal Vaccine

    • Biological: DTaP
    ACIP Recommended vaccine
    Other Names:
  • Diphtheria, Tetanus, and Acellular Pertussis Vaccine

    • Biological: HBV
    ACIP Recommended vaccine
    Other Names:
  • Hepatitis B Vaccine

    • Biological: IPV
    ACIP Recommended vaccine
    Other Names:
  • Inactivated Polio Vaccine

    • Biological: Hib
    ACIP Recommended vaccine
    Other Names:
  • Haemophilus influenzae Type B Vaccine

    		•
    No Intervention: Unvaccinated

    In the study arm, infants will not receive PCV13, DTaP, HBV, IPV, and Hib vaccines during the study. Infants will be monitored from randomization to 48 hours post-randomization for the occurrence of apnea, bradycardia and desaturation.

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Apnea [Up to 60 hours post-randomization]

      Proportion 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.

    Secondary Outcome Measures

    1. Number of Apneic Episodes [Up to 60 hours post-randomization]

      Average number of apneic episodes in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.

    2. Duration of Apneic Episodes [Up to 60 hours post-randomization]

      Average duration of apneic episodes in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.

    3. Increase in Respiratory Support [Up to 60 hours post-randomization]

      Proportion of infants requiring any increase in respiratory support in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.

    4. Severe Cardiorespiratory Events [Up to 60 hours post-randomization]

      Proportion of infants with severe ≥1 severe cardiorespiratory 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Weeks and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

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

    *This may result in a temporary delay of randomization

    1. Active infection being treated with systemic antimicrobials*

    *This may result in a temporary delay of randomization

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

    *This may result in a temporary delay of randomization

    1. History of unstable progressive neurologic disorder of unknown cause

    2. Known cause of apnea other than apnea of prematurity

    3. Cyanotic heart disease (congenital or acquired)

    4. 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

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

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centers for Disease Control and Prevention Atlanta Georgia United States 30333
    2 University of North Carolina Chapel Hill North Carolina United States 27599
    3 Duke University Durham North Carolina United States 27705
    4 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Duke University
    • Centers for Disease Control and Prevention
    • Children's Hospital Medical Center, Cincinnati
    • University of North Carolina

    Investigators

    • Principal Investigator: Rachel G Greenberg, MD, Duke University
    • Principal Investigator: Andrea Trembath, MD, University of North Carolina
    • Principal Investigator: Mary A Staat, MD, Children's Hospital Medical Center, Cincinnati
    • Principal Investigator: Patricia Wodi, MD, Centers for Disease Control and Prevention

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03530124
    Other Study ID Numbers:
    • Pro00088094
    • 200 2012 53663 0010
    First Posted:
    May 21, 2018
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Duke University
    apnea following vaccination
    Additional relevant MeSH terms:
    Apnea
    Vaccines
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Dec 14, 2021