Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Condition: Pain
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Sucrose solution 30%1 ml; Breastfeeding
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sucrose; Breastfeeding; Heel lance