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临床试验/CTRI/2024/06/069130
CTRI/2024/06/069130尚未招募不适用

A comparative study of oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year. A hospital based one year case control study

Jawaharlal Nehru Medical College KLE University Belgavi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To study oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year

研究概览

简要总结

Study is to compare the oral microbiota of infants with cleft lip-palate to that of normal infants in the age group 6 months to 1 year and the relation of their oral microbiota to the infections occuring in cleft lip-palate infants. The secondary purpose of this study is to compare the oral microbiota of cleft lip-palate infants preoperatively and 6 weeks postoperatively

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 1.00 Year(s)(—)
性别
All

入选标准

  • Group 1 Complete cleft lip-palate Gestational age over 37 weeks at birth Birth weight of 2000g Age group 6 months-1 year Group 2 Normal infants 6months-1year No congenital anomalies on clinical examination mother willing to sign for consent.

排除标准

  • Group 1 Syndromic clefts presurgical oral orthopedic devices Faliure to appear for follow up Acute infections Group 2 Acute infections.

结局指标

主要结局

To study oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year

时间窗: To study oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year

次要结局

  • To compare the preoperative oral microbiota in infants with cleft lip-palate to that of post operative 6 weeks after lip repair(The study will be conducted over a span of one year)

研究者

发起方
Jawaharlal Nehru Medical College KLE University Belgavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shirisha K N

Jawaharlal nehru medical college,kle university

研究点 (1)

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