- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00892476
Prevention of Myopia of Prematurity by Calcium Supplementation
Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Infants receive supplemental calcium in their 24 cal/oz formula or fortified breast milk.
|
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 Names:
|
Active Comparator: 2
Infants will receive fortified breast milk or 24 cal/oz formula
|
Infants are feed breast milk with fortifier or 24 cal/oz formula per standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
Time Frame: 6-12 months postnatal age
|
6-12 months postnatal age
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Supplementation of Ca will lead to increased cycloplegic refraction at 18-22 months corrected age.
Time Frame: 18-22 months corrected age
|
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
Time Frame: 6 months postnatal age to 18-22 months corrected age
|
6 months postnatal age to 18-22 months corrected age
|
Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.
Time Frame: 18-22 months corrected age
|
18-22 months corrected age
|
Supplementation of Ca will reduce the incidence of fractures.
Time Frame: birth to discharge
|
birth to discharge
|
Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.
Time Frame: birth to discharge
|
birth to discharge
|
Supplementation of Ca will not increase the incidence of feeding intolerance.
Time Frame: birth to discharge
|
birth to discharge
|
Supplementation of Ca is not associated with a change in the incidence of ROP.
Time Frame: birth to full vascularization of the retina
|
birth to full vascularization of the retina
|
Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).
Time Frame: 36 weeks postmenstrual age
|
36 weeks postmenstrual age
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F010613009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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