Iris Colors in Neonates: Do They Really Change? Prevalence, NCT03072368

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Not yet recruiting

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.

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	200
Est. completion date	April 1, 2018
Est. primary completion date	April 1, 2018
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	N/A to 2 Months
Eligibility	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

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

Locations
Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors *(1)*
Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Israel,

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