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ApneaPhase 4NCT03530124

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

A Phase 4 study testing PCV13, DTaP and HBV in people with Apnea and Apnea Neonatal, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 weeks and older
Conditions the study is for
Apnea, Apnea Neonatal, Prematurity
What is being tested?
PCV13, DTaP and HBV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
4 sitesUnited States
Study dates
17 Jul 2018to 1 Nov 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 weeks and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • <33 and 0 days weeks gestational age at birth
  • ≥6 weeks and 0 days and ≤12 weeks and 0 days 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

Who cannot join

  • 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
  • Fever ≥38°C within 48 hours prior to randomization*
Show all 20Show fewer
  • This may result in a temporary delay of randomization
  • Active known respiratory infection within 48 hours prior to randomization*
  • This may result in a temporary delay of randomization
  • Active infection being treated with systemic antimicrobials*
  • This may result in a temporary delay of randomization
  • 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)
  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Centers for Disease Control and Prevention

    Atlanta, Georgia, 30329

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Prospective, Randomized, Open-label Clinical Trial to Assess Apnea Following Administration of 13-valent Conjugate Pneumococcal Vaccine, Diphtheria Toxoid, Tetanus Toxoid, and Acellular Pertussis Vaccine, Inactivated Polio Vaccine, Hepatitis B Vaccine, and Haemophilus Influenzae Type B Vaccine in Preterm Infants

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.

Read the detailed description

Modified Intent-to-Treat (mITT) Analysis Population: Defined as any infant that was enrolled and randomized in the study

For the mITT analysis, infants will be analyzed in their assigned treatment arms irrespective of receipt of vaccine. Study outcomes will be included in the analysis as follows:

  1. Vaccinated group: study outcomes in the 48-hour monitoring after vaccination. If vaccination does not occur by 12 hours after randomization, then study outcomes will be assessed between 12 and 60 hours after randomization. ii) Unvaccinated group: study outcomes in the 48-hour monitoring period after randomization.
Being tested
PCV13, DTaP, HBV, IPV, Hib
Keywords
apnea following vaccination
Medical subject headings
Apnea, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCV13Biological

    Also called 13-valent Conjugate Pneumococcal Vaccine

    Advisory Committee on Immunization Practices (ACIP) Recommended vaccine

  • DTaPBiological

    Also called Diphtheria, Tetanus, and Acellular Pertussis Vaccine

    ACIP Recommended vaccine

  • HBVBiological

    Also called Hepatitis B Vaccine

    ACIP Recommended vaccine

  • IPVBiological

    Also called Inactivated Polio Vaccine

    ACIP Recommended vaccine

  • HibBiological

    Also called Haemophilus influenzae Type B Vaccine

    ACIP Recommended vaccine

Study groups in NCT03530124
Study groupRoleWhat they receive
VaccinatedOtherIn the study arm, infants will receive PCV13, DTaP, HBV, IPV, and Hib vaccines within 12 hours of randomization. Infants will be monitored from time of vaccination to 48 hours post-vaccination for the occurrence of apnea, bradycardia and desaturation.
Receives: Biological: PCV13; Biological: DTaP; Biological: HBV; Biological: IPV; Biological: Hib
UnvaccinatedNo interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Apnea

    Number 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, mITT Population

    Apnea was defined as a pause in respirations of >20 seconds, or a pause in respirations of >15 seconds with associated bradycardia (heart rate <80 beats per minute for any duration occurring within 1 minute of the apnea event). Potential apnea events triggered by the cardiorespiratory monitors were manually reviewed by 2 neonatologists to verify the event. In uncommon situations in which manual review of a triggered event was not possible due to missing data, the triggered event was considered to be apnea.

    Measured: 48 hours

Secondary outcomes (5)

  1. Number of Apneic Episodes

    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.

    Measured: 48 hours

  2. Duration of Apneic Episodes

    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.

    Measured: 48 hours

  3. Increase in Respiratory Support

    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.

    Measured: 48 hours

  4. Severe Cardiorespiratory Events

    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.

    Only severe apnea events in the mITT analysis window and only the severe bradycardia events in the mITT analysis window from Duke University. The monitor data were not viable at UNC and Cincinnati Children's Hospital. Duke data were adjudicated by neonatologists.

    Measured: 48 hours

  5. Positive Pressure Ventilation

    Proportion of Infants Requiring Positive Pressure Ventilation in a 48-hour monitoring period after vaccination in the "vaccinated" group and a 48-hour monitoring period after randomization in the "unvaccinated" group.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start17 Jul 2018
  3. Primary completion1 Nov 2021
  4. Study completion1 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530124
Sponsor's protocol ID
Pro00088094
Other IDs
200 2012 53663 0010
Status last verified
Feb 2024
First submitted
8 May 2018
Last updated
14 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greenberg RG, Rountree W, Staat MA, Schlaudecker EP, Poindexter B, Trembath A, Laughon M, Poniewierski MS, Spreng RL, Broder KR, Wodi AP, Museru O, Anyalechi EG, Marquez PL, Randolph EA, Aleem S, Kilpatrick R, Walter EB. Apnea After 2-Month Vaccinations in Hospitalized Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2025 Mar 1;179(3):246-254. doi: 10.1001/jamapediatrics.2024.5311.

    PubMed 39761016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PCV13, DTaP and HBV in people with Apnea and Apnea Neonatal, run by Duke University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Apnea (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

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