Trial | NCT00908401  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    42
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.
Study Started
Apr 30
2009
Primary Completion
Jul 31
2009
Anticipated
Study Completion
Jul 31
2009
Anticipated
Last Update
May 25
2009
Estimate

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

sucrose Active Comparator

This group will receive oral sucrose for procedural pain

breastmilk Experimental

this group will receive breastmilk as analgesic product to avoid procedural pain

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
No Results Posted