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Infant Weight Gain With Trisomy 21 and CAVC

2012年3月14日 更新者:Children's Healthcare of Atlanta

The Impact of Weight Gain in the Pre-operative Infant With Trisomy 21 (Down Syndrome) and Complete Atrioventricular Canal (CAVC)

Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC) frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5 kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome.

The purpose of this study is to determine the optimal timing for surgical correction of CAVC in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.

研究概览

地位

终止

详细说明

A retrospective chart review of 100 infants with Trisomy 21 and CAVC operated at CHOA at Egleston between January 1, 2001 and March 24, 2006 will be performed. Graphs of birth weight and rate of weight gain over time will be plotted for each patient and for the group as a whole. The point of reaching a plateau of weight gain will be decided for each patient and indexed for birth weight. Medical management will be detailed, i.e. all medications and all dietary information (caloric density of formula, route of administration). This medical management will be indexed as a function on the weight gain chart. Medical complications (such as respiratory infections, gastroenteritis, hospitalizations, and additional non-cardiac medications) will likewise be plotted and segmented according to position relative to the weight gain plateau. Age at eventual surgery and whether surgical date was delayed by complications will be noted. Surgical cardiopulmonary bypass time and morbidity and mortality will be noted. Postoperative length of ventilator support, length of stay in the CICU and total length of stay will be determined and also displayed as a function of body weight and as a function of time at plateau weight. Postoperative morbidity and mortality for the three months after repair will be noted, including all cause hospital re-admissions and outpatient medical complications (such as respiratory infections, gastroenteritis, and the need for continued medications for CHF).

研究类型

观察性的

注册 (实际的)

46

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30322
        • Children's Healthcare of Atlanta

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 1年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

patients' charts from Children's Healthcare of Atlanta

描述

Inclusion Criteria:

  • Infants with Trisomy 21 and CAVC operated on at CHOA at Egleston between January 1, 2001 and December 31, 2005 will be included in the study.

Exclusion Criteria:

  • Patients will be excluded if the following information is not available:

A. Birth weight B. Weight at operation C. Incomplete medical records e.g. patient followed preoperatively elsewhere

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tracy M Alderson, MD、Emory University @ Children's Healthcare of Atlanta

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2001年1月1日

初级完成 (实际的)

2006年3月1日

研究完成 (实际的)

2008年2月1日

研究注册日期

首次提交

2006年5月18日

首先提交符合 QC 标准的

2006年5月18日

首次发布 (估计)

2006年5月19日

研究记录更新

最后更新发布 (估计)

2012年3月16日

上次提交的符合 QC 标准的更新

2012年3月14日

最后验证

2008年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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