Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

NCT00482560 | Completed Phase 3

• 1 other identifier: PRN19341
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

Sucrose; Breastfeeding; Heel lance

Outcome Measures

Primary Outcomes (1)

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

  15 seconds before and Within 30 seconds after heel lance

Secondary Outcomes (5)

• 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

  within 2 minutes after heel lance

• Percentage of crying time

  During blood sampling

Interventions

Sucrose solution 30%1 ml DRUG

Breastfeeding BEHAVIORAL

Eligibility Criteria

• Age: 2 Days - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term neonates, gestational age 37-42 weeks
• Apgar \>= 7
• Not fed in the last 30 minutes
• Informant consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• Agnelli Hospital, Italy: collaborator

Study Sites (1)

Agnelli Hospital ASL 10

Pinerolo, Torino, 10064, Italy

Location

Related Publications (5)

• Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;(3):CD001069. doi: 10.1002/14651858.CD001069.pub2.

  PMID: 15266438 BACKGROUND

• Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.

  PMID: 12511452 BACKGROUND

• Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004950. doi: 10.1002/14651858.CD004950.pub2.

  PMID: 16856069 BACKGROUND

• Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.

  PMID: 10617258 BACKGROUND

• Codipietro L, Ceccarelli M, Ponzone A. Breastfeeding or oral sucrose solution in term neonates receiving heel lance: a randomized, controlled trial. Pediatrics. 2008 Sep;122(3):e716-21. doi: 10.1542/peds.2008-0221.

  PMID: 18762508 DERIVED

MeSH Terms

Conditions

Pain; Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Luigi Codipietro, MD

  University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry

  PRINCIPAL INVESTIGATOR

• Alberto Ponzone, MD

  University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: January 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 29, 2007

Record last verified: 2007-06

Locations

IT (1)