Clinical Trial: Human Papillomavirus 6/11 in the Lower Airway of Neonates

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Human Papillomavirus 6/11 in the Lower Airway of Neonates

Brief 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).

Detailed Summary:

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 diagno
Sponsor: National Taiwan University Hospital

Current 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 ]

Original 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).

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: October 24, 2007
Date Started: November 2007
Date Completion:
Last Updated: July 1, 2010
Last Verified: June 2010