At a glance
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Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
In Brief
A Phase 4 clinical trial evaluating expressed breast milk and sucrose 24% oral for Pain and 3 related conditions. Completed, enrolled 54 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk. A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk. A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.