Procedural Pain Clinical Trial
Official title:
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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