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

March 17, 2015 updated by: Laura Collados Gómez, Hospital General Universitario Gregorio Marañon

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hospital University Gregorio Maranon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: expressed breast milk

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.
Active Comparator: 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.
Behavioral: sucrose 24% oral

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain neonatal
Time Frame: 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.
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
Time Frame: 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.)
Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts
Time Frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months.
Number of attempts during the venopuncture
Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACTEET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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