Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

Study Overview
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Brief Summary
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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
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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).

Official Title
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Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

Conditions
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Pain

Intervention / Treatment
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* Drug: Sucrose solution 30%1 ml
* Behavioral: Breastfeeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sucrose solution 30%1 ml|nan|
|Behavioral: Breastfeeding|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile (PIPP) scale rate (0-21) |  | 15 seconds before and Within 30 seconds after heel lance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sucrose, Breastfeeding, Heel lance