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

Primary Purpose

Procedural Pain

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Breastmilk
Oral Sucrose
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Pain focused on measuring breastmilk, oral sucrose, analgesia, preterm neonates, Neonates

Eligibility Criteria

3 Days - 10 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Intercommunal de CreteilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sucrose

breastmilk

Arm Description

This group will receive oral sucrose for procedural pain

this group will receive breastmilk as analgesic product to avoid procedural pain

Outcomes

Primary Outcome Measures

Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose

Secondary Outcome Measures

Full Information

First Posted
May 22, 2009
Last Updated
May 22, 2009
Sponsor
Centre Hospitalier Intercommunal Creteil
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1. Study Identification

Unique Protocol Identification Number
NCT00908401
Brief Title
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
Acronym
BMoS
Official Title
Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Intercommunal Creteil

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain
Keywords
breastmilk, oral sucrose, analgesia, preterm neonates, Neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sucrose
Arm Type
Active Comparator
Arm Description
This group will receive oral sucrose for procedural pain
Arm Title
breastmilk
Arm Type
Experimental
Arm Description
this group will receive breastmilk as analgesic product to avoid procedural pain
Intervention Type
Other
Intervention Name(s)
Breastmilk
Intervention Description
Breastmilk: 0.2 ml
Intervention Type
Other
Intervention Name(s)
Oral Sucrose
Intervention Description
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Zana, MD
Phone
+33 1 45 17 54 39
Email
Elodie.Zana@chicreteil.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie Zana, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Creteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Creteil
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie Zana, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15188969
Citation
Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.
Results Reference
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PubMed Identifier
12511452
Citation
Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
Results Reference
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PubMed Identifier
9295899
Citation
Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.
Results Reference
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Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

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