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Status unknownNCT03072368Updated Mar 7, 2017

Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics

An interventional study of Photograph in Eye Color, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 2 Days to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
2 Days to 2 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Eye Color
03

In context

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 2 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Neonatal conjunctivitis
  • Neonatal sepsis
  • Inborn error of metabolism or genetic syndrome
  • Eye abnormalities
  • Parental refusal
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Blue eyes

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

    Other: Photograph

  • Active comparator
    Brown eyes

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

    Other: Photograph

  • Active comparator
    Green eyes

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

    Other: Photograph

  • Active comparator
    Hazel eyes

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

    Other: Photograph

Interventions

  • OtherPhotograph

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

06

What researchers measure

Primary outcomes

  1. Change in eye color

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

    Time frame: One year

07

Study locations

1 site
  • Hillel Yaffe Medical Center
    Hadera, 38100, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03072368
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Mar 7, 2017
Start date
Mar 2017 (estimated)
Primary completion
Apr 1, 2018 (estimated)
Completion
Apr 1, 2018 (estimated)
Last update
Mar 7, 2017

Study contacts

Amit Hochberg, MD
Contact
amith@hy.health.gov.il
Amit Hochberg, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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