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

Phase 4

Completed

• Conditions: Pain; Premature Infant; Human Milk; Breastfeeding
• Interventions: Other: expressed breast milk; Behavioral: sucrose 24% oral

• Registration Number: NCT02133716
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-17
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
expressed breast milk	expressed breast milk	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.
sucrose 24% oral	sucrose 24% oral	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.

Primary Outcome Measures

Name	Time	Method
Pain neonatal	Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital University Gregorio Marañon; 🇪🇸 Madrid, Spain