Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

June 28, 2007 updated by: University of Turin, Italy
The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance

Study Overview

Status

Completed

Conditions

Detailed Description

Blood sampling heel lance for neonatal screening is the most frequent painful manoeuvre in Neonatal Units in healthy neonates.

Some techniques showed efficacy evidence in reducing pain response: sucrose solutions, breastfeeding during blood sampling, topical local anaesthetics.

A Cochrane Review in 2004 recommends the administration of sucrose 0.24-0.48 g (1-2 ml of 24% sucrose solution). It reduces PIPP scale rate about 20%.

Our purpose is to compare the antinociceptive effect of 1 ml 30% sucrose solution administered 2 minutes before heel lancing vs blood sampling heel lance during breastfeeding.

PIPP scale is a validated 7-indicator scale for the assessment of procedural pain in preterm and term neonates.

Informant consent was asked parents during consultation by a Pediatrician of the Neonatal Unit of the Hospital in the last months of pregnancy.

After parent written consent was obtained, 100 three day old neonates were randomized for treatment A (breastfeeding) or B (sucrose solution administration). The nurse opened consecutively numbered envelopes.

Timing of operators: Group A Breastfeeding

  • The heel of neonate was warmed up by a glove full of water at 40° C for 2 minutes.
  • Monitoring of Oxygen Saturation and Heart Rate.
  • The neonate was breastfed by the mother till the nurse watched a continuous active suction.
  • Administration of first phase of PIPP scale (15 seconds before heel lance).
  • Digital Voice Record started
  • Heel Lance with an automated piercing device .
  • Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.
  • Administration of the second phase of PIPP scale.
  • Record of duration of blood sampling and collateral effects
  • Stop Digital Voice Recording

Group B Sucrose administration

  • The neonate was laid on a baby-changing table.
  • The heel of neonate was warmed up by a gloves full of water a 40° C for 2 minutes.
  • Oral administration of 1 ml of 30% sucrose solution.
  • Monitoring of Oxygen Saturation and Heart Rate.
  • Administration of first phase of PIPP scale (15 seconds before heel lance).
  • Digital Voice Record starts
  • Heel Lance with an automated piercing device.
  • Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.
  • Administration of the second phase of PIPP scale.Record of duration of blood sampling and collateral effects.
  • Stop Digital Voice Recording

Blood sampling was practiced by skilled pediatric nurses. Registration of data, PIPP scale, voice record was made by a second operator, blind to the pur pose of the study.

A third blind operator collected paper data and checked voice record (outcome cry behaviour).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

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

    • Torino
      • Pinerolo, Torino, Italy, 10064
        • Agnelli Hospital ASL 10

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

2 days to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term neonates, gestational age 37-42 weeks
  • Apgar >= 7
  • Not fed in the last 30 minutes
  • Informant consent

Exclusion Criteria:

  • Congenital malformation
  • Born in Caesarian Section in General Anaesthesia
  • Maternal use of opioids
  • Administration of Naloxone, Phenobarbital in the previous 48 hours
  • Impossibility of breastfeeding

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Premature Infant Pain Profile (PIPP) scale rate (0-21)
Time Frame: 15 seconds before and Within 30 seconds after heel lance
15 seconds before and Within 30 seconds after heel lance

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart Rate Increase
Time Frame: within 30 seconds after heel lance
within 30 seconds after heel lance
Oxygen Saturation decrease
Time Frame: within 30 seconds after heel lance
within 30 seconds after heel lance
Duration of first cry
Time Frame: within 2 minutes after heel lance
within 2 minutes after heel lance
Percentage of crying time
Time Frame: within 2 minutes after heel lance
within 2 minutes after heel lance
Percentage of crying time
Time Frame: During blood sampling
During blood sampling

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Luigi Codipietro, MD, University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
  • Study Chair: Alberto Ponzone, MD, University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry

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.

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

January 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2007

Last Update Submitted That Met QC Criteria

June 28, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • PRN19341

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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