Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482560
Status:
COMPLETED
Last Update Posted:
2007-06-29
First Post:
2007-06-04
Brief Title:
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 024-048 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 scaleRecord 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
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 024-048 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 scaleRecord 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None