NCT00549250

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 5, 2010

Status Verified

June 1, 2010

Enrollment Period

7 months

First QC Date

October 24, 2007

Last Update Submit

July 1, 2010

Conditions

Papillomavirus Infections

Keywords

Human papillomavirus 6/11NeonatesHuman papillomavirus 6 or 11 infection

Outcome Measures

Primary Outcomes (1)

  • 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).

    sampling time

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All intubated neonates younger than 1 month-old admitted to our neonatal intensive care unit.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchial lavage fluid

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li-Min Huang, M.D.Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2008

Study Completion

May 1, 2010

Last Updated

July 5, 2010

Record last verified: 2010-06

Locations

TW(1)