Maternal Oral Therapy to Reduce Obstetric Risk Kids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 4
- 主要终点
- MCHAT Score
研究概览
简要总结
The principal objective was to conduct a 5 year; multi-center, observational follow-up study enrolling infants born to mothers who participated in the MOTOR clinical trial to determine the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and mortality and whether this will result in lower incidence of functional neurological impairment.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Only a random sample of the low risk group will be recruited.
结局指标
主要结局
MCHAT Score
时间窗: 24 months
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.
次要结局
未报告次要终点