NCT02851251

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

July 28, 2016

Last Update Submit

September 21, 2021

Conditions

Eye Disease

Keywords

eye diseaseneonatal eye diseasenewbornscreeningmulticenter

Outcome Measures

Primary Outcomes (1)

  • presence of ocular disease

    2 to 7 days after birth

Eligibility Criteria

Age2 Days - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Otherwise healthy neonates in a multicenter network in China

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Peiquan Zhao, MD

    Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

CN(1)