Papillomavirus InfectionsNCT00549250
Human Papillomavirus 6/11 in the Lower Airway of Neonates
An observational study of Papillomavirus Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent respiratory papillomatosis (JORRP). Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Papillomavirus Infections
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: All intubated neonates younger than 1 month-old admitted to our neonatal intensive care unit.
Who may be able to join
- In order to get respiratory specimens at or below the larynx, intubated neonates younger than one-month-old admitted to our neonatal intensive care unit will be included in this study after getting informed consent from their families.
Who cannot join
- Unless the neonate's condition is too critical to have the following procedure performed, gestational age, co-morbidity and maternal status of HPV infection are not exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent respiratory papillomatosis (JORRP).
Read the detailed description
Juvenile onset recurrent respiratory papillomatosis (JORRP) is caused by human papillomavirus (HPV), almost exclusively type 6 and 11. The disease is well-known for its recurrence and difficulty in management. The peak incidence is around 2-3 year of age. Since HPV infection has always been considered a sexual transmitted disease, the rate of vertical or perinatal transmission had been studied extensively. However, few studies focused on HPV 6 and 11.
To the best of our knowledge, in the several large-scale studies available for HPV infection in the newborn, no case of HPV 6/11 infection had been identified. Most of these studies had specimens taken from the oral cavity of newborn. In contrast to the occurrence of JORRP in the larynx, trachea and lower respiratory tract, if vertical transmission of HPV 6/11 does exist, specimens from lower respiratory tract of newborn is mandatory to detect any possible infection.
There is no study available about HPV 6/11 infection in the lower airway of healthy neonate/children. In some studies of adults, the prevalence of HPV 6/11 in larynx or vocal cord of patients without recurrent respiratory papillomatosis ranged between 19~25%. In contrast, several studies had specimen taken from the non-disease lower airway (trachea, vocal cord) and/or larynx of patients with JORRP. Except for the almost 100% presence of HPV 6/11 DNA in the diseased site, 38~60% of specimens taken from non-disease site were also positive for the viral DNA, showing that latent infection is not infrequent in normal airway, and may later cause active disease by mechanism still unknown to date.
The largest national registry of JORRP to date was conducted in the US and had 603 cases. The study showed that there was a significant association between younger age at diagnosis and papillomas occurring below the larynx (mean age 4.6 VS 2.1 years, p=0.009). This finding further emphasizes the importance of getting specimen at the laryngeal level, especially in neonates.
The aim of our study is to examine the presence of HPV 6/11 DNA in lower respiratory tract specimens from newborn. To get the lower respiratory tract specimen without unnecessary medical intervention, only those needed intubation will be included in this study. Specimens from bronchial lavage (or scraping?) will be obtained after getting informed consent from the parents, and undergo PCR to identify the presence of HPV 6/11 DNA.
- Conditions
- Papillomavirus Infections
- Keywords
- Human papillomavirus 6/11, Neonates, Human papillomavirus 6 or 11 infection
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to identify prospectively the presence and the estimated prevalence of HPV 6/11 DNA in the lower airway of neonates by polymerase chain reaction (PCR).
Measured: sampling time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Li-Min Huang, M.D.Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549250
- Sponsor's protocol ID
- 200710007R
- Status last verified
- Jun 2010
- First submitted
- 24 Oct 2007
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus 6/11 in the Lower Airway of Neonates
- ClinicalTrials.gov ID
- NCT00549250
- Acronym / sponsor ID
- 200710007R
- Conditions
- Papillomavirus Infections
- Keywords
- Human papillomavirus 6/11, Neonates, Human papillomavirus 6 or 11 infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent respiratory papillomatosis (JORRP).
Detailed description
Juvenile onset recurrent respiratory papillomatosis (JORRP) is caused by human papillomavirus (HPV), almost exclusively type 6 and 11. The disease is well-known for its recurrence and difficulty in management. The peak incidence is around 2-3 year of age. Since HPV infection has always been considered a sexual transmitted disease, the rate of vertical or perinatal transmission had been studied extensively. However, few studies focused on HPV 6 and 11.
To the best of our knowledge, in the several large-scale studies available for HPV infection in the newborn, no case of HPV 6/11 infection had been identified. Most of these studies had specimens taken from the oral cavity of newborn. In contrast to the occurrence of JORRP in the larynx, trachea and lower respiratory tract, if vertical transmission of HPV 6/11 does exist, specimens from lower respiratory tract of newborn is mandatory to detect any possible infection.
There is no study available about HPV 6/11 infection in the lower airway of healthy neonate/children. In some studies of adults, the prevalence of HPV 6/11 in larynx or vocal cord of patients without recurrent respiratory papillomatosis ranged between 19~25%. In contrast, several studies had specimen taken from the non-disease lower airway (trachea, vocal cord) and/or larynx of patients with JORRP. Except for the almost 100% presence of HPV 6/11 DNA in the diseased site, 38~60% of specimens taken from non-disease site were also positive for the viral DNA, showing that latent infection is not infrequent in normal airway, and may later cause active disease by mechanism still unknown to date.
The largest national registry of JORRP to date was conducted in the US and had 603 cases. The study showed that there was a significant association between younger age at diagnosis and papillomas occurring below the larynx (mean age 4.6 VS 2.1 years, p=0.009). This finding further emphasizes the importance of getting specimen at the laryngeal level, especially in neonates.
The aim of our study is to examine the presence of HPV 6/11 DNA in lower respiratory tract specimens from newborn. To get the lower respiratory tract specimen without unnecessary medical intervention, only those needed intubation will be included in this study. Specimens from bronchial lavage (or scraping?) will be obtained after getting informed consent from the parents, and undergo PCR to identify the presence of HPV 6/11 DNA.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All intubated neonates younger than 1 month-old admitted to our neonatal intensive care unit.
Key inclusion criteria (1 listed)
- In order to get respiratory specimens at or below the larynx, intubated neonates younger than one-month-old admitted to our neonatal intensive care unit will be included in this study after getting informed consent from their families.
Key exclusion criteria (1 listed)
- Unless the neonate's condition is too critical to have the following procedure performed, gestational age, co-morbidity and maternal status of HPV infection are not exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The purpose of this study is to identify prospectively the presence and the estimated prevalence of HPV 6/11 DNA in the lower airway of neonates by polymerase chain reaction (PCR).
Time frame: sampling time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Min Huang, M.D.Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The purpose of this study is to identify prospectively the presence and the estimated prevalence of HPV 6/11 DNA in the lower airway of neonates by polymerase chain reaction (PCR). (time frame: sampling time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2010.