NCT00908401
Unknown
Phase 3
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
ConditionsProcedural Pain
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Procedural Pain
- Sponsor
- Centre Hospitalier Intercommunal Creteil
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
- Last Updated
- 16 years ago
Overview
Brief Summary
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.
The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.
Investigators
Eligibility Criteria
Inclusion Criteria
- •preterm neonates born before 27 and 29+6 weeks GA
- •blood sampling procedure
- •obtention of parental consent
Exclusion Criteria
- •congenital malformation
- •intravenous continuous analgesia
- •contraindications to feed
- •high grade intracerebral hemorrhage
Outcomes
Primary Outcomes
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
Time Frame: One time during day 3 or 4 then day 7 to 10
Study Sites (1)
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