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

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.

Study Overview

• Status: Unknown
• Conditions: Eye Color
• Intervention / Treatment: Other: Photograph

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
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; Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
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; Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
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; Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eye color	Change will be measured according to a validated classification of blue/hazel/green or brown	One year

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Amit Hochberg, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HYMC-0081-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No