PainPhase 3NCT00482560
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
A Phase 3 study testing Sucrose solution 30%1 ml and Breastfeeding in people with Pain, run by University of Turin, Italy at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 5 days
- Conditions the study is for
- Pain
- What is being tested?
- Sucrose solution 30%1 ml and Breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term neonates, gestational age 37-42 weeks
- Apgar >= 7
- Not fed in the last 30 minutes
- Informant consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Conditions
- Pain
- Being tested
- Sucrose solution 30%1 ml, Breastfeeding
- Keywords
- Sucrose, Breastfeeding, Heel lance
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose solution 30%1 mlDrug
BreastfeedingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile (PIPP) scale rate (0-21)
Measured: 15 seconds before and Within 30 seconds after heel lance
Secondary outcomes (5)
Heart Rate Increase
Measured: within 30 seconds after heel lance
Oxygen Saturation decrease
Measured: within 30 seconds after heel lance
Duration of first cry
Measured: within 2 minutes after heel lance
Percentage of crying time
Measured: within 2 minutes after heel lance
Percentage of crying time
Measured: During blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Agnelli Hospital, Italy
- Investigators
- Luigi Codipietro, MD, Principal investigator, University of Turin Department of Paediatric Science Doctorate in Experimental PediatryAlberto Ponzone, MD, Study chair, University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482560
- Sponsor's protocol ID
- PRN19341
- Status last verified
- Jun 2007
- First submitted
- 4 Jun 2007
- Last updated
- 29 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15266438Carbajal 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.
PubMed 12511452Shah 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.
PubMed 16856069Ballantyne 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.
PubMed 10617258Codipietro 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.
PubMed 18762508
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
- ClinicalTrials.gov ID
- NCT00482560
- Acronym / sponsor ID
- PRN19341
- Conditions
- Pain
- Keywords
- Sucrose, Breastfeeding, Heel lance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Agnelli Hospital, Italy
- Study start
- Jan 2007
- Study completion
- Apr 2007 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term neonates, gestational age 37-42 weeks
- Apgar >= 7
- Not fed in the last 30 minutes
- Informant consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrose solution 30%1 ml | Drug | – |
| Breastfeeding | Behavioural | – |
Primary outcome
Premature Infant Pain Profile (PIPP) scale rate (0-21)
Time frame: 15 seconds before and Within 30 seconds after heel lance
5 secondary outcomes
Heart Rate Increase
Time frame: within 30 seconds after heel lance
Oxygen Saturation decrease
Time frame: within 30 seconds after heel lance
Duration of first cry
Time frame: within 2 minutes after heel lance
Percentage of crying time
Time frame: within 2 minutes after heel lance
Percentage of crying time
Time frame: During blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2007.
- Background: PubMed 15266438Stevens 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.
- Background: PubMed 12511452Carbajal 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.
- Background: PubMed 16856069Shah 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.
- Background: PubMed 10617258Ballantyne 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.
- Derived from this study: PubMed 18762508Codipietro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Codipietro, MD principal investigator
University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
Alberto Ponzone, MD study chair
University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sucrose solution 30%1 ml and Breastfeeding in people with Pain, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Infant Pain Profile (PIPP) scale rate (0-21) (time frame: 15 seconds before and Within 30 seconds after heel lance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482560, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2007.