PainPhase 3TRAKCNCT01561547
Trial of Repeated Analgesia With Kangaroo Care
A Phase 3 study testing Kangaroo Mother Care and Sucrose in people with Pain and Development, run by IWK Health Centre at 1 site in Canada.
Trial summary
Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Development
- What is being tested?
- Kangaroo Mother Care and Sucrose
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- less than 36.0 weeks gestational age
- mother is generally available to provide kangaroo mother care
Who cannot join
- narcotic analgesics
- surgery in past 48 hrs
- major congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?
Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.
AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.
- Conditions
- Pain, Development
- Being tested
- Kangaroo Mother Care, Sucrose
- Keywords
- pain, preterm neonate, sucrose, kangaroo mother care
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareBehavioural
Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.
SucroseDietary supplement
24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Mother Care | Experimental | Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal. Receives: Behavioral: Kangaroo Mother Care |
| Sucrose | Active comparator | Two minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important. Receives: Dietary Supplement: Sucrose |
| Combination Kangaroo Mother Care and Sucrose | Experimental | Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal. Receives: Behavioral: Kangaroo Mother Care; Dietary Supplement: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile (PIPP)
The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.
Measured: At the moment of painful procedure
Secondary outcomes (1)
Neurobehavioral Assessment of Preterm Infants (NAPI)
Two scales of the NAPI will be scored by person blinded to the intervention. These are 1) Motor Development and Vigour and 2) Alertness and Orientation
Measured: 32, 36 and 40 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Mayday Fund
- Responsible party
- Principal investigator, Celeste Johnston, IWK Health Centre
- Investigators
- Celeste Johnston, RN, DEd, Principal investigator, IWK Health CentreMarsha Campbell-Yeo, RN, NNP, PhD, Study director, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561547
- Sponsor's protocol ID
- TRAKC
- Other IDs
- CIHR-NSHRF-Mayday RPP 2446
- Acronym
- TRAKC
- Status last verified
- Sep 2016
- First submitted
- 8 Mar 2012
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate data will be available but no individual data will be provided.
Publications
Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.
PubMed 21893645Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13.
PubMed 18435837Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
PubMed 14609899Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
PubMed 12205254Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.
PubMed 20091512Vinall J, Noel M, Disher T, Caddell K, Campbell-Yeo M. Memories of Infant Pain in the Neonatal Intensive Care Unit Influence Posttraumatic Stress Symptoms in Mothers of Infants Born Preterm. Clin J Pain. 2018 Oct;34(10):936-943. doi: 10.1097/AJP.0000000000000620.
PubMed 29698249Campbell-Yeo M, Johnston C, Benoit B, Latimer M, Vincer M, Walker CD, Streiner D, Inglis D, Caddell K. Trial of repeated analgesia with Kangaroo Mother Care (TRAKC Trial). BMC Pediatr. 2013 Nov 9;13:182. doi: 10.1186/1471-2431-13-182.
PubMed 24284002
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?
- ClinicalTrials.gov ID
- NCT01561547
- Acronym / sponsor ID
- TRAKC / TRAKC
- Conditions
- Pain, Development
- Keywords
- pain, preterm neonate, sucrose, kangaroo mother care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Mayday Fund
- Study start
- Jun 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Mar 2012 (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.
Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.
AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Mother Care | Experimental | Behavioral: Kangaroo Mother CareInfant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal. |
| Sucrose | Active comparator | Dietary Supplement: SucroseTwo minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important. |
| Combination Kangaroo Mother Care and Sucrose | Experimental | Behavioral: Kangaroo Mother Care, Dietary Supplement: SucroseInfant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- less than 36.0 weeks gestational age
- mother is generally available to provide kangaroo mother care
Key exclusion criteria (3 listed)
- narcotic analgesics
- surgery in past 48 hrs
- major congenital anomalies
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 |
|---|---|---|
| Kangaroo Mother CareInfant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal. | Behavioural | Combination Kangaroo Mother Care and Sucrose, Kangaroo Mother Care |
| Sucrose24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses. | Dietary supplement | Combination Kangaroo Mother Care and Sucrose, Sucrose |
Primary outcome
Premature Infant Pain Profile (PIPP)
Time frame: At the moment of painful procedure
The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.
1 secondary outcome
Neurobehavioral Assessment of Preterm Infants (NAPI)
Time frame: 32, 36 and 40 weeks gestational age
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 20 Sep 2016.
- Background: PubMed 21893645Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.
- Background: PubMed 18435837Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13.
- Background: PubMed 14609899Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
- Background: PubMed 12205254Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
- Background: PubMed 20091512Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.
- Derived from this study: PubMed 29698249Vinall J, Noel M, Disher T, Caddell K, Campbell-Yeo M. Memories of Infant Pain in the Neonatal Intensive Care Unit Influence Posttraumatic Stress Symptoms in Mothers of Infants Born Preterm. Clin J Pain. 2018 Oct;34(10):936-943. doi: 10.1097/AJP.0000000000000620.
- Derived from this study: PubMed 24284002Campbell-Yeo M, Johnston C, Benoit B, Latimer M, Vincer M, Walker CD, Streiner D, Inglis D, Caddell K. Trial of repeated analgesia with Kangaroo Mother Care (TRAKC Trial). BMC Pediatr. 2013 Nov 9;13:182. doi: 10.1186/1471-2431-13-182.
- Individual participant dataSharing planned: No. Aggregate data will be available but no individual data will be provided.
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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.
Celeste Johnston, RN, DEd principal investigator
IWK Health Centre
Marsha Campbell-Yeo, RN, NNP, PhD study director
IWK Health Centre
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 Kangaroo Mother Care and Sucrose in people with Pain and Development, run by IWK Health Centre at 1 site in Canada.
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 2 inclusion and 3 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 20 Sep 2016. 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 Canada. 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) (time frame: At the moment of painful procedure). 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 NCT01561547, which also lists 7 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 20 Sep 2016.