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Trial record 69 of 3329 for:    China Medicine University Hospital

Multicenter Neonatal Eye Disease Screening in China

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ClinicalTrials.gov Identifier: NCT02851251
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
These exams are vital to protect healthy neonates from blindness. The purpose of this study is to better screen ocular disease in otherwise healthy neonates using wide-field digital imaging system (RetCam III) in a multi-center network in China leaded by Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The multi-center network will be built with the collaboration of eight hospitals from different parts of China.

Condition or disease
Eye Disease

Detailed Description:
Studies reveal that ocular anomalies may also be found in healthy full-term babies. These abnormal ocular findings included subconjunctival haemorrhage, congenital microphthalmos, congenital corneal leukoma, posterior synechia, persistent pupillary membrane, congenital cataract, enlarged C/D ratio, retinal hamartoma versus retinoblastoma, optic nerve defects, macular pigment disorder and non-specific peripheral retinopathy. The highest proportion of these abnormal findings is retinal haemorrhages, accounting for 92% of abnormalities. Most retinal hemorrhages are benign and will finally self-resolve. However, sometimes it takes a long time for the hemorrhage to resolve. Some slow-resolving hemorrhages could obstruct the visual axis and may do great harm to visual development in critical period. Some neonatal eye diseases are time sensitive, such as retinoblastoma, and if found late, the best opportunity for effective treatment is missed, leading to irreversible visual impairment. Newborns are unable to express their discomforts or visual disorders as adults do and only through an examination, the neonatal eye diseases can be detected. Therefore, this screening protocol is designed to screen the otherwise healthy neonates in a multi-center network on neonatal ophthalmopathy and to achieve early diagnosis and timely treatment. All the neonates will undergo eye examination by using RetCam III. The external eye, pupillary light reflex, red reflex, opacity of refractive media, anterior chamber and posterior segments will be examined. The outcomes will be analyzed by a blinded specialist in order to discover serious congenital, hereditary and acquired diseases in the neonatal period of healthy newborns and to improve epidemiological information of neonatal ophthalmopathy. Neonatal ocular examination may play a positive role in promoting paediatric eye health to paediatricians and parents.

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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Neonatal Eye Disease Screening in China
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases




Primary Outcome Measures :
  1. presence of ocular disease [ Time Frame: 2 to 7 days after birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Otherwise healthy neonates in a multicenter network in China
Criteria

Inclusion Criteria:

  • Otherwise healthy neonates ( ≥37weeks' gestational age, weighing ≥2500 g, no evidence of systemic disease and an Apgar score of 7 or more.)

Exclusion Criteria:

  • Preterm /Neonates with systemic diseases
  • Neonates unable to undergo the examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851251


Contacts
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Contact: Peiquan Zhao, MD 13311620396 zhaopeiquan@126.com
Contact: Ping Fei, MD,PhD 13636342098 shirleypingfei@126.com

Locations
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China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Contact: Peiquan Zhao, MD,PhD    13311620396    zhaopeiquan@126.com   
Contact: Ping Fei, MD,PhD    13636342098    shirleypingfei@126.com   
Principal Investigator: Peiquan Zhao, MD,PhD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Peiquan Zhao, MD Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, China

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Responsible Party: Peiquan Zhao, Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02851251     History of Changes
Other Study ID Numbers: XH-16-019
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
eye disease
neonatal eye disease
newborn
screening
multicenter

Additional relevant MeSH terms:
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Eye Diseases