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

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ClinicalTrials.gov Identifier: NCT03072368
Recruitment Status : Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Eye Color Other: Photograph Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2018

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




Primary Outcome Measures :
  1. Change in eye color [ Time Frame: One year ]
    Change will be measured according to a validated classification of blue/hazel/green or brown



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072368


Contacts
Contact: Amit Hochberg, MD amith@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Amit Hochberg, MD Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03072368     History of Changes
Other Study ID Numbers: HYMC-0081-16
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No