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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:9/14/2018
Start Date:July 17, 2018
End Date:November 14, 2020
Contact:Rachel G Greenberg, MD
Email:rachel.greenberg@duke.edu
Phone:919-668-4725

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
4
sites
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Rachel G Greenberg, MD
Phone: 919-668-4725
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Mary A Staat, MD
Phone: 513-636-2877
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Atlanta, Georgia 30333
Principal Investigator: Patricia Wodi, MD
Phone: 404-498-6431
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Andrea N Trembath, MD
Phone: 984-974-5063
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials