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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Centre Hospitalier Intercommunal Creteil.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT00908401
First received: May 22, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Procedural Pain
 Other: Breastmilk
Other: Oral Sucrose
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

Resource links provided by NLM:

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

Further study details as provided by Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 22, 2009
Last Updated: May 22, 2009
Health Authority: France: Ministry of Health

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
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013