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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00908401
Study type Interventional
Source Centre Hospitalier Intercommunal Creteil
Contact Elodie Zana, MD
Phone +33 1 45 17 54 39
Email Elodie.Zana@chicreteil.fr
Status Recruiting
Phase Phase 3
Start date April 2009
Completion date July 2009

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