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More info
You can access this
clinical trial
if you have
Procedural Pain
and you are
under 10
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Other: Breastmilk
  • Other: Oral Sucrose
Tris trial is registered with FDA with number: NCT00908401. The sponsor of the trial is Centre Hospitalier Intercommunal Creteil and it is looking for 42 volunteers for the current phase.
Official trial title:
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study