Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Phase 3

• Conditions: Procedural Pain
• Interventions: Other: Oral Sucrose; Other: Breastmilk

• 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

Arm && Interventions

Group	Intervention	Description
sucrose	Oral Sucrose	This group will receive oral sucrose for procedural pain
breastmilk	Breastmilk	this group will receive breastmilk as analgesic product to avoid procedural pain

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