Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00482560
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
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:
NCT00482560
Study Brief:
Protocol Section:
NCT00482560