Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants (BMoS)

May 22, 2009 updated by: Centre Hospitalier Intercommunal Creteil

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Creteil, France, 94000
        • Recruiting
        • Centre hospitalier intercommunal de Créteil
        • Principal Investigator:
          • Elodie Zana, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sucrose
This group will receive oral sucrose for procedural pain
Other: Oral Sucrose
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Experimental: breastmilk
this group will receive breastmilk as analgesic product to avoid procedural pain
Other: Breastmilk
Breastmilk: 0.2 ml

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Investigators

  • Principal Investigator: Elodie Zana, MD, Centre Hospitalier Intercommunal Créteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 25, 2009

Last Update Submitted That Met QC Criteria

May 22, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHICreteil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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