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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014