Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants

Centre Hospitalier Intercommunal Creteil42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Procedural Pain

Interventions

BreastmilkOTHER

Breastmilk: 0.2 ml

Oral SucroseOTHER

oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier

Eligibility

Sex: ALLMin age: 3 DaysMax age: 10 Days

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Intercommunal de Creteil

Créteil, France

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Elodie Zana, MD

CONTACT

+33 1 45 17 54 39 Elodie.Zana@chicreteil.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.