Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
研究概览
简要总结
Previous research studies have shown that there may be a connection between proton pump inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux medications raise the pH of the stomach, which may effect the body's ability to absorb certain calcium compounds.
Neonates are at a crucial age for bone mineralization. Because esophageal reflux is common in neonates, PPI therapy is commonly used, despite little information on effectiveness and side effects. PPIs work by blocking the production of protons in the pumps in the stomach, thus making the stomach less acidic. The calcium ion needs an acidic environment in order to be broken down from its natural compounds into an absorbable form (2). This is troubling because of the problems associated with osteopenia in neonates. Bone mineralization is important for premature infants. Rickets and bone fractures are higher in preterm infants than term infants. For this reason, we are investigating whether there is a connection between PPI therapies (specifically Prevacid) and decreased bone densities in neonates.
The objective is to determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
详细描述
After a patient is screened and consent is obtained, participants will all be initially placed into group one. Patients will be later moved to group two if their treatment includes proton pump inhibitors.
Group 1: Patients that meet the selection criteria that are not currently receiving any treatments for reflux or have other excluding conditions.
Group 2: Patients that meet the selection criteria and are receiving proton pump inhibitors as part of their treatment in the NBICU.
Participants in both groups will receive a bone density ultrasound when they begin full feeds, and every two weeks following until discharge. Participants will not be asked to participate in scans post discharge.
Because most babies do not begin GER therapy until some time after they have reached full feedings, they will be placed in group two retrospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight Parental consent has been obtained
排除标准
- •Infants with bone disorders, liver or kidney problems, infants of diabetics, growth retarded infants, or infants taking diuretics or chronic steroids will be excluded.
结局指标
主要结局
To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
时间窗: 18 months
次要结局
未报告次要终点