MedTrace Logo

Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

NCT00908401 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2009-05-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Principal Investigators

  • Elodie Zana, MD · Centre Hospitalier Intercommunal Creteil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908401 on ClinicalTrials.gov