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Completed

NCT Number: NCT00482560

Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

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

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Key information

Age range

2 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agnelli Hospital ASL 10

Pinerolo, Torino, 10064, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucrose solution 30%1 ml

Drug

breastfeeding

Behavioral

Primary outcomes

  1. Premature Infant Pain Profile (PIPP) scale rate (0-21)

    Time frame: 15 seconds before and Within 30 seconds after heel lance

Secondary outcomes

  1. Heart Rate Increase

    Time frame: within 30 seconds after heel lance

  2. Oxygen Saturation decrease

    Time frame: within 30 seconds after heel lance

  3. Duration of first cry

    Time frame: within 2 minutes after heel lance

  4. Percentage of crying time

    Time frame: within 2 minutes after heel lance

  5. Percentage of crying time

    Time frame: During blood sampling

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Agnelli Hospital, Italy

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Jun 5, 2007
Registry last updated
Jun 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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