Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Phase 3

• Conditions: Procedural Pain

• Registration Number: NCT00908401
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-05
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Last Update Submitted: 2009-05-22
• Study First Posted: 2009-05-25
• Last Update Posted: 2009-05-25
• Primary Completion: 2009-07
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose	One time during day 3 or 4 then day 7 to 10

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Creteil; 🇫🇷 Creteil, France