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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00908401
Recruitment Status : Unknown
Verified May 2009 by Centre Hospitalier Intercommunal Creteil.
Recruitment status was:  Recruiting
First Posted : May 25, 2009
Last Update Posted : May 25, 2009
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Procedural Pain Other: Breastmilk Other: Oral Sucrose Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
Study Start Date : April 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908401


Contacts
Contact: Elodie Zana, MD +33 1 45 17 54 39 Elodie.Zana@chicreteil.fr

Locations
France
Centre Hospitalier Intercommunal de Creteil Recruiting
Creteil, France, 94000
Principal Investigator: Elodie Zana, MD         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
Principal Investigator: Elodie Zana, MD Centre Hospitalier Intercommunal Creteil
More Information

Publications:
Responsible Party: Centre Hospitalier Intercommunal de Creteil
ClinicalTrials.gov Identifier: NCT00908401     History of Changes
Other Study ID Numbers: CHICreteil
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 2009

Keywords provided by Centre Hospitalier Intercommunal Creteil:
breastmilk
oral sucrose
analgesia
preterm neonates
Neonates

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs