Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

Study Overview
=================
Brief 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.

Official Title
-----------------
Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.

Conditions
-----------------
Pain, Premature Infant, Human Milk, Breastfeeding

Intervention / Treatment
-----------------
* Other: expressed breast milk
* Behavioral: sucrose 24% oral


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: expressed breast milk<br>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. | Other: expressed breast milk<br>* 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.<br>|
| Active Comparator: sucrose 24% oral<br>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. | Behavioral: sucrose 24% oral<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain neonatal | The pain neonatal will be determined by the scale Premature Infant Pain Profile (PIPP). The PIPP scale is a multidimensional measure developed to assess pain in preterm and term infants. It consists of three behavioral indicators (facial actions: philtrum, frowning, clenched eyes), two physiological indicators (heart rate and oxygen saturation) and two measures of development (gestational age and behavioral state). Each pointer may take four values on a scale from 0 to 3, which is subsequently added to an overall score. The score range from 0 (no pain or the presence of minimal pain) to 21 (maximum pain) in preterm. PIPP score was evaluated at 30 seconds after venopuncture Both the validity and reliability of this scale have been studied and proven in various studies. The PIPP scale will it be monitored by skilled and experienced nurses in neonatal care. | Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of crying | Relationship between duration procedure venipuncture and the time or duration of crying(from beginning to cry until terminated.) | Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, premature infant, sucrose, breastfeeding, expressed breast milk, PIPP