A Phase 3 interventional study of Breastfeeding and 24% oral sucrose in Pain and Neonatal, sponsored by Britney Benoit. Completed at 1 site in Canada. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2019-11-08.
Sponsored by Britney Benoit · Phase 3, Interventional, and Treatment
Among 461 studies in Pain with a site in Canada — 62 open to participants now, 66 under way, 1 of them phase 3. Pain · Canada.
Among the 461 studies in Pain with a site in Canada, this one is the 301st largest by enrollment of the 417 interventional ones that give a count, is one of 21 that started in 2017, is one of 67 in phase 3, and was the 289th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →62 of the 461 studies in Pain with a site in Canada are open now. Recruiting first, the newest first:
University of British Columbia · Sites in Canada
Ages 50+
University of British Columbia · Sites in Canada
Ages 19+ · Women only
St. Justine's Hospital · Sites in Canada
Ages 18+ · Women only
London Health Sciences Centre Research Institute · Sites in Canada
Ages 1–17
Universite de Picardie Jules Verne · Sites in Canada, France
Ages 18–35 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: Up to 72 Hours · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
461 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 67 · Phase 3 74 · Phase 4 48
First in 1997; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 39 is below the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 65 across the 417 interventional studies, 153 across the 42 observational. Of the 325 that completed or were terminated, 49 (15%) have results posted.
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76 of 461 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Britney Benoit as lead sponsor.
Britney Benoit has 1 study filed under Pain — fewer than ten, so there is no comparison to draw.
26 of the studies in Pain with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07681180Olivier F. BertrandEvaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies | 2026-12 |
| NCT07562048University of CalgaryTherapeutic Cuddling in Critically Ill Children | 2026-12 |
| NCT07447830McGill UniversityThe Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study | 2026-12-01 |
| NCT07016373Nancy MouradianRole of Manuka Honey in Lowering Pain and Boosting Healing After Gum Graft Surgery. | 2026-12-26 |
Add all 26 to your calendar (.ics) → With an account.
Among the 461 studies in Pain with a site in Canada, from their registry updates:
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Background: Even the healthiest infants undergo painful procedures as part of universal medical care. Untreated early pain is associated with heightened pain response during later procedures in infancy and alteration in response to pain in childhood. Oral sucrose is currently considered the standard of care for acute pain relief in infants. Compelling evidence from 57 randomized controlled trials suggests that oral sucrose reduces bio-behavioral pain response. However, recent data examining the influence of oral sucrose on pain-specific brain activity measured using electroencephalogram (EEG) questions the efficacy of this intervention for reducing pain in the infant brain. Evidence supports the effectiveness of breastfeeding as a pain relieving intervention, however, no studies to date have examined the effect of breastfeeding on pain-specific activity in the newborn brain.
Aims: The primary aim of this study is to examine the influence of breastfeeding in comparison to oral sucrose on pain-specific activity in the newborn brain during a heel lance. The secondary aim will be to determine if there is convergence among outcome measures in either of the intervention conditions.
Methods: Utilizing a single blind, randomized controlled trial design, 126 healthy term infants will be recruited within the first two days of life. Infants will be randomized to have a medically indicated heel lance completed in one of two possible conditions: 1) breastfeeding (n = 63) or 2) sucrose in an infant cot (n = 63). Infants will not be eligible for study participation if they show signs of lower limb tissue damage, have had previous surgery or intraventricular hemorrhage, are born to opioid using mothers or with significant genetic disorders, are unable to breastfeed, or have contraindications to sucrose administration. Pain-specific brain activity will be recorded on EEG for the duration of the blood collection. Infant facial response will be video recorded, and heart rate and oxygen saturation will be measured for calculation of Premature Infant Pain Profile-Revised (PIPP-R) Score, a reliable and valid bio-behavioral measure of pain in infants' 26-44 weeks gestational age. For infants randomized to the breastfeeding condition, data collection will begin with recording of a one-minute baseline (BL1). Following this, a non-painful control stimulus will be applied to the infant's foot to capture a baseline response on EEG to a non-painful event. The infant will then be transferred to the mother and active breastfeeding will be facilitated. A second baseline (BL2) will be recorded prior to heel lance. Pain response will be recorded from the initiation of the heel lance until procedure completion. In the sucrose condition, all monitoring will take place while the infant is in a cot (considered standard of care). Procedures will be consistent with those outlined above with the exception of administration of 24% oral sucrose two minutes prior to the heel lance. Analysis and inference will be calculated based on the intention-to-treat principle. Data from the EEG recording will be grouped into basic waveforms using principal component analysis. Two one-way analysis of variances will be used to assess the effect of stimulation type (non-painful control, painful heel lance) and treatment (24% oral sucrose, breastfeeding) on the principal components. To assess for the effect of treatment on PIPP-R score, group means will be compared using unpaired Student's t-tests.
Hypotheses: Infants in the breastfeeding condition will demonstrate both lower pain-specific brain response and lower bio-behavioral pain scores than infants in the sucrose condition.
Significance: This will be the first study to examine the effect of breastfeeding on pain-specific brain response in infants. In light of the negative consequences of unmanaged pain in infants, it is imperative that effective pain relieving interventions are utilized. Given recent evidence questioning the analgesic properties of sucrose, findings will have important implications for informing optimal pain management practices in infants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Breastfeeding
Drug: 24% oral sucrose
Infants will be placed in skin-to-skin contact with their mother at least five minutes prior to heel lance to allow time to settle and initiate breastfeeding. Breastfeeding position will be determined based on individual maternal preference in order to optimize feeding as well as to facilitate ease of access to the infant's foot for blood collection, while also attempting to minimize disruption of continuous EEG, heart rate, oxygen saturation, and video recording. Active breastfeeding will be facilitated to ensure it takes place for a minimum of two minutes prior to heel lance, and will continue until the procedure is completed.
Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance. Non-nutritive sucking will be offered using a gloved finger or pacifier (based on parental preference) immediately following administration of the complete 24 percent oral sucrose dose.
Pain-specific event related potential
The primary outcome measure will be pain-specific brain activity measured using a dense array neonatal electroencephalogram (EEG) recording that is time-locked to a medically required heel lance. Infant EEG activity will be recorded from a HydroCel Geodesic Sensor Net positioned according to the modified international 10/20 electrode placement system on a 128 Channel Geodesic EEG SystemTM 400 MR series (Electrical Geodesics Incorporated, Eugene, Oregon, USA). Pain-specific event related potentials will specifically be examined and isolated at electrode sites Cz, as previous research has reported pain-specific activity at this site in both infants and adults.
Time frame: Isolated within the one-minute window post-procedure.
Premature Infant Pain Profile-Revised
The PIPP-R, which has been revised from the original PIPP developed 14 years ago, is a 7-indicator composite pain measure consisting of 3 behavioural (facial actions: brow bulge, eye squeeze, and naso-labial furrow), 2 physiological (heart rate, oxygen saturation) and 2 contextual (gestational age, behavioural state) indicators of acute pain. A numerical score ranging from 0 - 3 is assigned to each indicator for a maximum score of 18 reflecting the worst possible pain in infants born at greater than 36 weeks' gestational age. A score of 6 or less is considered to indicate minimal or no pain, a score of 6 to 12 indicates mild or moderate pain, and a score of 12 or greater indicates moderate to severe pain.
Time frame: Baseline, 30, 60, 90, 120 seconds post-procedure.
Recovery
Time to recovery will be considered the amount of time in seconds that elapses until the infant's heart rate returns to baseline average values. The point at which the infant's heart rate reaches baseline levels and is sustained for no less than five to seven beats following the heel lance will indicate recovery.
Time frame: In the 30 minute window post-procedure.
Maternal acceptability
Mothers will be asked to complete an open-ended questionnaire with 3-5 questions (depending on assigned condition) following completion of the study procedures. This questionnaire will focus on assessing maternal acceptability of the use of the assigned breastfeeding or sweet taste intervention as well as the use of neurophysiological imaging technology to measure newborn pain responding in the neonatal period.
Time frame: Immediately post-procedure.
Plan to share: No
Ran from Nov 2017 to primary completion in Jan 2019, 14 months.
Of 110 non-industry phase 3 interventional studies under Pain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 14 months is below that.
Counting every sponsor, half of 215 studies reached it within 18 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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