NCT00908401

Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 3 Days – 10 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Procedural Pain

Interventions

Type	Name	Description
OTHER	Breastmilk	Breastmilk: 0.2 ml
OTHER	Oral Sucrose	oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-05-25
• Last updated: 2009-05-25

Locations

1 site across 1 country: France