Prevention of Myopia of Prematurity by Calcium Supplementation
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myopia
Intervention: Calcium Supplementation (Dietary Supplement); Standard of Care (Other)
Phase: Phase 1
Status: Completed
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s): Waldemar Carlo, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
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 months postnatal age.
Secondly, the study will determine if calcium supplementation is well tolerated, if it
reduces the molding of these premature infants' heads, and if it decreases myopia at the
18-22 month postnatal age visit.
Clinical Details
Official title: Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
Secondary outcome: Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.Supplementation of Ca will lead to an increased cycloplegic refraction at 6-12 months postnatal age and at 18-22 months corrected age in infants who had no abdominal surgery or prolonged feeding intolerance Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index. Supplementation of Ca will reduce the incidence of fractures. Supplementation of Ca will not increase the incidence of NEC stage 2A or greater. Supplementation of Ca will not increase the incidence of feeding intolerance. Supplementation of Ca is not associated with a change in the incidence of ROP. Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).
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 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.
Written informed consent of one parent or legal guardian must be obtained. The infants are
randomized to receive unsupplemented feedings of breast milk or formula, or feedings
supplemented with Ca-gluconate as outlined below.
Randomization will be stratified into the following groups: 401-750 g and 751-1000 g and
performed according to a balanced block scheme with variable block size (2-6) using sealed
opaque envelopes.
Total parenteral nutrition is given by nursery unit standards. Infant positioning is done by
nursery unit standards.
Feeding mixtures:
Supplementation is started when enteral feeding amounts to 100 ml/kg. At that time,
fortification is also introduced in infants receiving breast milk. Fortified human milk or
24 cal/oz formula, e. g. Similac Special Care 24 (SSC24), is used in all participating
infants. Human milk is fortified with 1 pk Enfamil human milk fortifier per 25 ml (BMHMF).
Control group: Fortified human milk or 24 cal/oz formula. Supplemented group: Ca-gluconate
powder (molar weight 430. 4 g) will be measured with household measuring spoons (e. g.
Rubbermaid (R)) and added to the feeding mixtures.
One eye exam will be performed at 6-12 months during routine follow-up visit. A second eye
exam will be performed at 18-2 months during a follow-up visit which is part of the NICHD
newborn follow-up clinic. Head measurements, specifically, front-to-back and side-to-side
will be measured at randomization, 36 weeks postmenstrual age or discharge, whichever occurs
first, and during the follow up visits. Urinalysis will be collected weekly.
Eligibility
Minimum age: N/A.
Maximum age: 14 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days
Exclusion Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: February 2002
Last updated: December 4, 2012
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