Prevention of Myopia of Prematurity by Calcium Supplementation

Myopia Clinical Trial

Official title:

Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892476
• Other study ID #: F010613009
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: December 4, 2012
• Start date: February 2002
• Est. completion date: December 2008

Study information

• Verified date: July 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2008
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia
• Premature Birth

Intervention

Dietary Supplement:
• Calcium Supplementation
Ca-gluconate powder (molar weight 430.4 g) will be measured with household measuring spoons and added to the feeding mixtures as follows: Amount of feeding Actual Weight < 1000 g Actual Weight < 1000 g 25 ml ¼ tsp 1/8 tsp 50 ml ½ tsp ¼ tsp 100 ml 1 tsp ½ tsp 200 ml 2 tsp 1 tsp

Other:
• Standard of Care
Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.		6-12 months postnatal age	No
Secondary	Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.		18-22 months corrected age	No
Secondary	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		6 months postnatal age to 18-22 months corrected age	No
Secondary	Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.		18-22 months corrected age	No
Secondary	Supplementation of Ca will reduce the incidence of fractures.		birth to discharge	No
Secondary	Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.		birth to discharge	No
Secondary	Supplementation of Ca will not increase the incidence of feeding intolerance.		birth to discharge	No
Secondary	Supplementation of Ca is not associated with a change in the incidence of ROP.		birth to full vascularization of the retina	No
Secondary	Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).		36 weeks postmenstrual age	No