Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
NCT ID: NCT00482560
Last Updated: 2007-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2007-01-31
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sucrose solution 30%1 ml
Breastfeeding
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Apgar \>= 7
* Not fed in the last 30 minutes
* Informant consent
Exclusion Criteria
* Born in Caesarian Section in General Anaesthesia
* Maternal use of opioids
* Administration of Naloxone, Phenobarbital in the previous 48 hours
* Impossibility of breastfeeding
2 Days
5 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Agnelli Hospital, Italy
OTHER
University of Turin, Italy
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luigi Codipietro, MD
Role: PRINCIPAL_INVESTIGATOR
University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
Alberto Ponzone, MD
Role: STUDY_CHAIR
University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Agnelli Hospital ASL 10
Pinerolo, Torino, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRN19341
Identifier Type: -
Identifier Source: org_study_id