CTRI/2026/02/103167尚未招募2 期
Feeding aid for infants with cleft palate
Saveetha medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a Phase II single blind parallel group randomized controlled trial evaluating a feeding bottle with an integrated cleft palate occluder in infants with cleft palate
A total of 60 infants will be randomly allocated to receive either the occluder integrated bottle or standard cleft feeding methods
The trial aims to assess early weight gain feeding efficiency and safety including nasal regurgitation and aspiration events
Outcomes will be measured longitudinally over the study period and compared between groups
The study is designed to generate evidence for a low-cost practical feeding intervention suitable for routine clinical use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Infants aged 0 to 6 months till 1year with diagnosed cleft lip and or cleft palate awaiting surgical repair 2 Difficulty in feeding confirmed by caregiver or clinical observation such as poor intake frequent nasal regurgitation 3 Medically stable and able to attempt oral feeding.
- •4 Informed parental consent obtained.
排除标准
- •1 Syndromic clefts with associated severe comorbidities such as cardiac anomalies neurological conditions affecting swallowing 2 Infants requiring bottle feeding for other reasons such as non medical reasons 3 Infants with recurrent pneumonia more than 2 hospitalisation 4 Known severe allergy to medical-grade silicone/plastics used in device.
研究者
PRADEEP S
Saveetha medical college and hospital
研究点 (1)
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