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
  Show Detailed Description

  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 July 23, 2014