Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
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ClinicalTrials.gov Identifier: NCT03530124 |
Recruitment Status :
Completed
First Posted : May 21, 2018
Last Update Posted : December 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Apnea Apnea Neonatal Prematurity | Biological: PCV13 Biological: DTaP Biological: HBV Biological: IPV Biological: Hib | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 17, 2018 |
Actual Primary Completion Date : | November 1, 2021 |
Actual Study Completion Date : | November 1, 2021 |
Arm | Intervention/treatment |
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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.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.

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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 |
Inclusion Criteria:
- ≤32 weeks gestational age at birth
- ≥6 weeks postnatal age at randomization
- Remains hospitalized after birth (has never been discharged home)
- Treating clinician deems infant eligible to receive 2-month vaccines
- English- or Spanish-speaking parent(s)/legally authorized representative(s) (LAR(s))
- Not planned for discharge within 60 hours of study entry
- The parent/guardian must be willing and capable of providing permission for their child to participate through the written informed consent process
Exclusion Criteria:
- Receipt of DTaP, IPV, PCV13, or Hib prior to enrollment. Previous administration of the first dose of HBV is permitted
- Anticipated receipt of any vaccine other than DTaP, IPV, HBV, PCV13, or Hib during the first 60 hours after randomization
- History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any hepatitis B vaccine
- 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
- History of latex allergy
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Fever ≥38°C within 48 hours prior to randomization*
*This may result in a temporary delay of randomization
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Active known respiratory infection within 48 hours prior to randomization*
*This may result in a temporary delay of randomization
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Active infection being treated with systemic antimicrobials*
*This may result in a temporary delay of randomization
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Requiring mechanical ventilation or support with nasal intermittent positive pressure ventilation (NIPPV)*
*This may result in a temporary delay of randomization
- History of unstable progressive neurologic disorder of unknown cause
- Known cause of apnea other than apnea of prematurity
- Cyanotic heart disease (congenital or acquired)
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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
- Child or parent/LAR is an immediate relative of study staff or an employee who is supervised by study staff.
- 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

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
United States, Georgia | |
Centers for Disease Control and Prevention | |
Atlanta, Georgia, United States, 30333 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
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 |
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: | December 14, 2021 |
Last Verified: | December 2021 |
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 |
apnea following vaccination |
Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |