Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Procedural Pain Clinical Trial

— BMoS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00908401
• Other study ID #: CHICreteil
• Status: Recruiting
• Phase: Phase 3
• First received: May 22, 2009
• Last updated: May 22, 2009
• Start date: April 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2009
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Elodie Zana, MD
• Phone: +33 1 45 17 54 39
• Email: Elodie.Zana[@]chicreteil.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Procedural Pain

Intervention

Other:
• Breastmilk
Breastmilk: 0.2 ml
• Oral Sucrose
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Creteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (3)

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. French. — View 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. — View Citation

Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose		One time during day 3 or 4 then day 7 to 10	No