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Clinical Trials/NCT00482560
NCT00482560CompletedPhase 3

Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

University of Turin, Italy2 sites in 1 country100 target enrollmentStarted: January 1, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Premature Infant Pain Profile (PIPP) scale rate (0-21)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Days to 5 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Premature Infant Pain Profile (PIPP) scale rate (0-21)

Time Frame: 15 seconds before and Within 30 seconds after heel lance

Secondary Outcomes

  • Heart Rate Increase(within 30 seconds after heel lance)
  • Oxygen Saturation decrease(within 30 seconds after heel lance)
  • Duration of first cry(within 2 minutes after heel lance)
  • Percentage of crying time(During blood sampling)

Investigators

Sponsor
University of Turin, Italy
Sponsor Class
Other

Study Sites (2)

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