Clinical trial NCT00482560: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Official title: Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Sucrose
Breastfeeding
Heel lance
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Agnelli Hospital, Italy
First posted: 2007-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Premature Infant Pain Profile (PIPP) scale rate (0-21)
timeFrame: 15 seconds before and Within 30 seconds after heel lance
Secondary outcomes:
measure: Heart Rate Increase
timeFrame: within 30 seconds after heel lance
measure: Oxygen Saturation decrease
timeFrame: within 30 seconds after heel lance
measure: Duration of first cry
timeFrame: within 2 minutes after heel lance
measure: Percentage of crying time
timeFrame: within 2 minutes after heel lance
measure: Percentage of crying time
timeFrame: During blood sampling
Other outcomes:
Locations:
city: Pinerolo
country: Italy
facility: Agnelli Hospital ASL 10
state: Torino
Study officials:
affiliation: University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
name: Luigi Codipietro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
name: Alberto Ponzone, MD
role: STUDY_CHAIR
References:
citation: Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;(3):CD001069. doi: 10.1002/14651858.CD001069.pub2.
citation: Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
citation: Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004950. doi: 10.1002/14651858.CD004950.pub2.
citation: Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.
citation: Codipietro L, Ceccarelli M, Ponzone A. Breastfeeding or oral sucrose solution in term neonates receiving heel lance: a randomized, controlled trial. Pediatrics. 2008 Sep;122(3):e716-21. doi: 10.1542/peds.2008-0221.