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

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ClinicalTrials.gov Identifier: NCT03530124
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Children's Hospital Medical Center, Cincinnati
University of North Carolina
Information provided by (Responsible Party):
Duke University

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
Apnea Apnea Neonatal Prematurity Biological: PCV13 Biological: DTaP Biological: HBV Biological: IPV Biological: Hib Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : July 17, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : November 14, 2020

Arm Intervention/treatment
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 Name: 13-valent Conjugate Pneumococcal Vaccine

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

Biological: HBV
ACIP Recommended vaccine
Other Name: Hepatitis B Vaccine

Biological: IPV
ACIP Recommended vaccine
Other Name: Inactivated Polio Vaccine

Biological: Hib
ACIP Recommended vaccine
Other Name: 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.



Primary Outcome Measures :
  1. Occurrence of Apnea [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530124


Contacts
Contact: Rachel G Greenberg, MD 919-668-4725 rachel.greenberg@duke.edu
Contact: Christopher A Todd, MPH 919-681-7791 chris.todd@duke.edu

Locations
United States, Georgia
Centers for Disease Control and Prevention Not yet recruiting
Atlanta, Georgia, United States, 30333
Contact: Patricia Wodi, MD    404-498-6431    awodi@duke.edu   
Contact: Karen R Broder, MD       krb2@cdc.gov   
Principal Investigator: Patricia Wodi, MD         
Sub-Investigator: Karen R Broder, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Andrea Trembath, MD    984-974-5063    atrembat@email.unc.edu   
Contact: Matthew M Laughon, MD    984-974-5063    matt_laughon@med.unc.edu   
Principal Investigator: Andrea N Trembath, MD         
Sub-Investigator: Matthew M Laughon, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Rachel G Greenberg, MD    919-668-4725    rachel.greenberg@duke.edu   
Contact: Christopher A Todd, MPH    919-681-7791    chris.todd@duke.edu   
Principal Investigator: Rachel G Greenberg, MD         
Sub-Investigator: Emmanuel B Walter, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Mary A Staat, MD    513-636-2877    mary.staat@cchmc.org   
Contact: Brenda Poindexter, MD    513-636-0252    brenda.poindexter@cchmc.org   
Principal Investigator: Mary A Staat, MD         
Sub-Investigator: Brenda Poindexter, MD         
Sub-Investigator: Elizabeth Schlaudecker, MD         
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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03530124     History of Changes
Other Study ID Numbers: Pro00088094
200 2012 53663 0010 ( Other Grant/Funding Number: CDC )
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs