ChiCTR2200059635Not yet recruitingEarly Phase 1
关于比较捐赠母乳、亲母母乳和葡萄糖水缓解新生儿操作性疼痛效果的前瞻性对照研究
自筹1 site in 1 country87 target enrollmentStarted: May 6, 2022Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- NIPS 疼痛得分
Study Overview
Brief Summary
比较捐赠母乳、亲母母乳和葡萄糖水缓解新生儿操作性疼痛效果
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Ages
- 0 to 0 (—)
- Sex
- All
Inclusion Criteria
- •1.胎龄在 26-37 周；
- •2.体重＜1500g；
- •3.住院期间签署捐赠母乳使用知情同意书并应用捐赠母乳；
- •4.患儿父母签署知情同意书。
Exclusion Criteria
- •1.持续处于药物镇静状态；
Arms & Interventions
捐赠母乳组
足跟采血或静脉穿刺前 2 分钟给与患儿捐赠母乳 2ml 口服
亲母母乳组
足跟采血或静脉穿刺前 2 分钟给与患儿亲母母乳 2ml 口服
10%葡萄糖水组
足跟采血或静脉穿刺前 2 分钟给与患儿葡萄糖水 2ml 口服
Outcomes
Primary Outcomes
NIPS 疼痛得分
Time Frame: 操作前中后
PIPP-R 疼痛得分
Time Frame: 操作前中后
哭闹情况
Time Frame: 操作过程中以及操作后 10min
Secondary Outcomes
- 生命体征(操作前中后)
- 喂养不耐受(干预后 2 天内)
- 高血糖(干预后 2 天内)
Investigators
Study Sites (1)
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