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

Centre Hospitalier Intercommunal Creteil

Status and phase: Unknown; Phase 3

Conditions: Procedural Pain

Treatments: Other: Oral Sucrose; Other: Breastmilk

Study type: Interventional

Funder types: Other

Identifiers

NCT00908401

CHICreteil

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 3 to 10 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

42 participants in 2 patient groups

sucrose

Active Comparator group

Description:

This group will receive oral sucrose for procedural pain

Treatment:

Other: Oral Sucrose

breastmilk

Experimental group

Description:

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

Treatment:

Other: Breastmilk