Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

This study has been completed.
Sponsor:
Collaborator:
Agnelli Hospital, Italy
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00482560
First received: June 4, 2007
Last updated: June 28, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Pain
Drug: Sucrose solution 30%1 ml
Behavioral: Breastfeeding
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

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

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

Enrollment: 100
Study Start Date: January 2007
Study Completion Date: April 2007
  Hide Detailed Description

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).

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482560

Locations
Italy
Agnelli Hospital ASL 10
Pinerolo, Torino, Italy, 10064
Sponsors and Collaborators
University of Turin, Italy
Agnelli Hospital, Italy
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00482560     History of Changes
Other Study ID Numbers: PRN19341
Study First Received: June 4, 2007
Last Updated: June 28, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
Sucrose
Breastfeeding
Heel lance

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014