Trial record 1 of 17 for:
Duke | apnea
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
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| ClinicalTrials.gov Identifier: NCT03530124 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2018
Last Update Posted : September 12, 2018
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Sponsor:
Duke University
Collaborators:
Centers for Disease Control and Prevention
Children's Hospital Medical Center, Cincinnati
University of North Carolina
Information provided by (Responsible Party):
Duke University
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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 |
|---|---|
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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 |
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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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Primary Outcome Measures :
- 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 :
- 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 |
Criteria
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
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:
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apnea following vaccination |
Additional relevant MeSH terms:
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Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |