Ambulatory Blood Pressure Measurement in Children With Congenital Urine Flow Obstruction
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
PURPOSE - HYPOTHESIS:
Children with unilateral congenital urine flow impairment, who require surgery, have abnormal 24-hour ambulatory blood pressure measurements.
OBJECTIVES:
To Measure 24-hour ambulatory blood pressure in children who have unilateral hydronephrosis or multicystic-dysplastic kidneys.
To compare these blood pressure measurements between the children who require surgical correction and those who do not need surgical correction.
BACKGROUND:
With the introduction of ultrasound examinations of pregnant women, previously undetected abnormalities in the fetus are being detected. Dilatation of the kidney caused by congenital unilateral impairment to the urine flow either partial, presenting as unilateral hydronephrosis or complete, as seen in children with multicystic-dysplastic kidneys, id a common finding affecting approximately 1: 1,500 pregnancies (Cendron et al 1994). The majority of infants do not require surgery, with only 25% needing surgery by 18 months of age (Ransley 1991). However, i8n a few. There is an increase in renal dilatation which ultimately results in a reduction in renal function.
The decision to operate is dependent on changes in renal pelvic diameter observed on serial ultrasound scans and on renal function. This process is often lengthy an requ8ires numerous scans, which can be upsetting for parents and child. M<any techniques have been used to identify, early, those patients who will require surgery. These have included: Intra-0renal pressure measurements, renal function, and calyceal diameter (Feung L 1997). To date, none have shown to be better than ultrasound (Dhillion HK 1998).
Ambulatory blood pressure monitoring measures the blood pressure multiple times during a predefined period. It, therefore, more accurately reflects the continuous nature of blood pressure during both awake and sleep periods (Sorof JM 2001). Consequently, it may detect abnormalities in blood pressure that are missed on a single reading. This has been shown in the one previous study investigating ambulatory blood pressure and patient with multicystic dysplastic kidneys (Seeman T et al Eur J Pediatr 2001). In this study, 20% of the children studied had abnormal results when ambulatory blood pressure was monitored.
详细描述
Patients who have a unilateral congenital impairment to urine flow, either partially or complete, will be included in this study. Only patients of investigators will be recruited for this study. Patients will be identified during their first clinic visit to see the urologist. If determined to be an eligible study candidate, they will be invited to join the research study.
Children enrolled at three months of age will be seen on their 6th, 12th, and 24th month and will take home a 24-hour ambulatory blood pressure monitor on each visit.
Children enrolled at 6 to 18 months of age will be seen every six months until their 24th month. They will also take home a 24-hout blood pressure monitor on each visit.
When the patient is enrolled in the study, they will follow the study design outlined in TABLE 1. The Table outlines scheduled intervals of clinic visits during which clinic staff and physicians will provide the standard of care required by the child, radiology procedure(s) required by the child's condition, and the initiation of the research-specific procedure of 24-Hour Ambulatory Blood Pressure Monitoring. Each visit will take approximately 2-3 hours. All care outlined in TABLE 1 are the standard of care except for the 24-Hour Ambulatory Blood Pressure Monitoring.
Clinic visits will encompass vital sign measurements in w2hich a single Blood Pressure will be measured, physical exam by the physician, and physician/parent discussion abo9ut the child's medical condition. These selected activities are estimated to take 30-45 minutes.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of all races and both sexes including Spanish-speaking under 24 months of age with unilateral hydronephrosis greater than 10-mm in anterior posterior diameter; multicystic-dysplastic kidney on ultrasound examination.
排除标准
- •Children over 24 months of age who have undergone surgery and whose parents do not wish to be involved in the study.
研究者
Nancy Rollins
Assoc Dean
University of Texas Southwestern Medical Center