Prevention of Myopia of Prematurity by Calcium Supplementation in a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days
排除标准
- •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.
结局指标
主要结局
Supplementation of Ca by the enteral route to ELBW infants will lead to an increased cycloplegic refraction at 6-12 months postnatal age.
时间窗: 6-12 months postnatal age
次要结局
- Supplementation of Ca will not increase the incidence of NEC stage 2A or greater.(birth to discharge)
- Supplementation of Ca is not associated with a change in the incidence of ROP.(birth to full vascularization of the retina)
- Supplementation of Ca will lead to increased cycloplegic refraction at 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(6 months postnatal age to 18-22 months corrected age)
- Supplementation of Ca will reduce the incidence of fractures.(birth to discharge)
- Supplementation of Ca will reduce the dolichocephalic deformation of the infants' heads as measured by the FOD/BPD index.(18-22 months corrected age)
- Supplementation of Ca will increase bone mineral density at 36 weeks postmenstrual age (only relevant if measurement is available).(36 weeks postmenstrual age)
- Supplementation of Ca will not increase the incidence of feeding intolerance.(birth to discharge)