Status:

COMPLETED

Prevention of Myopia of Prematurity by Calcium Supplementation

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Myopia

Eligibility:

All Genders

1-14 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to determine if supplementation of calcium by the enteral route (gut feeding) to extremely low birth weight infants will lead to less myopia (nearsightedness) at 6-12 mont...

Detailed Description

All infants admitted meeting the 401-1000gm birthweight and less than 14 day of age entry criteria will be screened for entry into the study. Infants may be excluded for the following: Major congenita...

Eligibility Criteria

Inclusion

  • Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days

Exclusion

  • Major congenital malformations including
  • complex congenital heart disease (except open ductus arteriosus, atrial and ventricular septal defects)
  • pulmonary malformations
  • bowel or anal stenosis or atresia
  • renal dysplasias
  • chromosomal anomalies
  • hydrops fetalis
  • bowel perforation or necrotizing enterocolitis stage 2A or greater before randomization.

Key Trial Info

Start Date :

February 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

99 Patients enrolled

Trial Details

Trial ID

NCT00892476

Start Date

February 1 2002

End Date

December 1 2008

Last Update

December 5 2012

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