- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00482560
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Torino
-
Pinerolo, Torino, Italy, 10064
- Agnelli Hospital ASL 10
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Premature Infant Pain Profile (PIPP) scale rate (0-21)
Time Frame: 15 seconds before and Within 30 seconds after heel lance
|
15 seconds before and Within 30 seconds after heel lance
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart Rate Increase
Time Frame: within 30 seconds after heel lance
|
within 30 seconds after heel lance
|
Oxygen Saturation decrease
Time Frame: within 30 seconds after heel lance
|
within 30 seconds after heel lance
|
Duration of first cry
Time Frame: within 2 minutes after heel lance
|
within 2 minutes after heel lance
|
Percentage of crying time
Time Frame: within 2 minutes after heel lance
|
within 2 minutes after heel lance
|
Percentage of crying time
Time Frame: During blood sampling
|
During blood sampling
|
Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRN19341
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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