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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 : Unknown
Verified February 2017 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date March 7, 2017
Estimated Study Start Date  ICMJE March 2017
Estimated Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Change in eye color [ Time Frame: One year ]
Change will be measured according to a validated classification of blue/hazel/green or brown
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
Official Title  ICMJE Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Eye Color
Intervention  ICMJE Other: Photograph
Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Other: Photograph
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2018
Estimated Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03072368
Other Study ID Numbers  ICMJE HYMC-0081-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hillel Yaffe Medical Center
Study Sponsor  ICMJE Hillel Yaffe Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Hochberg, MD Hillel Yaffe Medical Center
PRS Account Hillel Yaffe Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP