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Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482560
First Posted: June 5, 2007
Last Update Posted: June 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agnelli Hospital, Italy
Information provided by:
University of Turin, Italy
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00482560     History of Changes
Other Study ID Numbers: PRN19341
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: June 29, 2007
Last Verified: June 2007

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