NCT03072368

Brief Summary

The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

February 27, 2017

Last Update Submit

March 1, 2017

Conditions

Eye Color

Outcome Measures

Primary Outcomes (1)

  • Change in eye color

    Change will be measured according to a validated classification of blue/hazel/green or brown

    One year

Study Arms (4)

Blue eyes

ACTIVE COMPARATOR

50 babies born with blue eyes will be photographed and followed-up at baseline; 3 months and 12 months of age

Other: Photograph

Brown eyes

ACTIVE COMPARATOR

50 babies born with brown eyes will be photographed and followed-up at baseline; 3 months and 12 months of age

Other: Photograph

Green eyes

ACTIVE COMPARATOR

50 babies born with green eyes will be photographed and followed-up at baseline; 3 months and 12 months of age

Other: Photograph

Hazel eyes

ACTIVE COMPARATOR

50 babies born with hazel eyes will be photographed and followed-up at baseline; 3 months and 12 months of age

Other: Photograph

Interventions

PhotographOTHER

Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age

Blue eyesBrown eyesGreen eyesHazel eyes

Eligibility Criteria

Age2 Days - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.

You may not qualify if:

  • Neonatal conjunctivitis
  • Neonatal sepsis
  • Inborn error of metabolism or genetic syndrome
  • Eye abnormalities
  • Parental refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

Moire Topography

Intervention Hierarchy (Ancestors)

PhotogrammetryPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInterferometryInvestigative Techniques

Study Officials

  • Amit Hochberg, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Hochberg, MD

CONTACT

amith@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 7, 2017

Study Start

March 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)