Maternal Oral Therapy to Reduce Obstetric Risk Kids (MOTORKids)
研究概览
详细说明
A total of 525 infants where planned to be enrolled at the 3 performance sites. The number of infants enrolled at each site depended on past Motor recruitment rates, and the observed delivery rate of high risk babies at that site. Infants were enrolled from both the high risk and low risk groups. The intended sample size was fixed, over sampling among the low risk group and was used to assure the sample size.
The Data Coordinating Center (DCC) identified and provided each clinical site with participant listings of all MOTOR high risk births and a randomly ordered sample of low risk births for enrollment into the study.
Mothers where approached by MOTOR or MOTORkids personnel to ascertain participant interest in enrolling their infant. Once consent was obtained, infants were followed and tracked until scheduled for the follow-up exams at age 24 months +/- 2 months adjusted age.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35249
- University of Alabama at Birmingham Department of Ostetrics and Gynecology
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- Department of Periodontology, UNC School of Dentistry
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Durham、North Carolina、美国、27705
- Duke University
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Texas
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San Antonio、Texas、美国、78229
- University of Texas Health Science Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All infants born to mothers enrolled to MOTOR study prior to 35 weeks gestational age,
- All small for gestational age (SGA) infants and all infants born after 37 weeks gestation and who were appropriate for gestational age are eligible for enrollment.
- All infants born < 34 weeks gestation and all SGA infants will be considered a high risk infant and will be recruited for enrollment.
- Appropriate weight for gestational age infants born after 37 weeks will be considered low risk infants and a random sample of these infants will be recruited for enrollment.
Exclusion Criteria:
- Only a random sample of the low risk group will be recruited.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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High Risk Infants
Motor infants born prior to 35 weeks gestational age, or, infants small (<10th percentile) for gestational age.
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Low Risk Infants
Motor infants born after the completion of the 37th week of gestation and appropriate for gestational age.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MCHAT Score
大体时间：24 months
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MCHAT composite risk score for Autism questionnaire is a 20-item screening tool completed by parents of children aged 16-30 months to evaluate Autism Spectrum Disorder (ASD) risk.
Score ranges include 0 to 20 with 2 or less indicating low-risk, 3-7 medium-risk and 8-20 indicating high-risk.
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24 months
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合作者和调查者
调查人员
- 首席研究员：Carl Bose, MD、University of North Carolina, Chapel Hill
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.