Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm (LACTEET)

Hospital General Universitario Gregorio Marañon

Status and phase: Completed; Phase 4

Conditions: Human Milk; Breastfeeding; Premature Infant; Pain

Treatments: Behavioral: sucrose 24% oral; Other: expressed breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02133716

LACTEET

Details and patient eligibility

About

The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.

This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid.

The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose.

The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture.

The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry.

Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

Enrollment: 54 estimated patients

Sex: All

Ages: 25 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm neonates.
• Weight less than 2500 grams.
• Feed breastfeeding (exclusive or not) or can obtain weight expressed breastmilk .
• Be informed and consent to the parents of those infants previously requested.

Exclusion criteria

• Maternal use of opioids or insulin-depent
• infants with invasive artificial respiration
• infants with major congenital anomalies
• infants with grade II or IV intraventricular hemorrhage or strokes
• receiving parental sedatives or vasoactive drugs
• infants with necrotizing enterocolitis
• with surgical interventions
• infants in absolute diet
• infants with abstinence syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

expressed breast milk

Experimental group

Description:

A single dose of expressed breast milk was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment. The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks.

Treatment:

Other: expressed breast milk

sucrose 24% oral

Active Comparator group

Description:

A single dose of sucrose was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment. The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks.

Treatment:

Behavioral: sucrose 24% oral