PainPhase 1NCT00175409
Breast Feeding Analgesia in Preterm Infants
A Phase 1 study testing Blood collection in people with Pain, run by University of British Columbia at 2 sites in Canada.
Trial summary
The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 3 days to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 1
- 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 3 days to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born between 30-36 weeks gestational age
- breastfeeding
- mother has fluent English
Who cannot join
- CNS injury
- congenital anomaly
- active infection
- has had surgeries or analgesics/sedatives in last 72 hours
- history of maternal drug exposure
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Lions Gate Hospital - Special Care Nursery
North Vancouver, British Columbia
Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery
Vancouver, British Columbia, V6H 3V4
About this study
The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
- When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
Read the detailed description
Research Method:
In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
- Conditions
- Pain
- Being tested
- Blood collection
- Keywords
- Pain Response
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
Blood collectionProcedure or surgery
For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. Receives: Procedure: Blood collection |
| 2 | Active comparator | Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection. Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Videotaped and recorded at Baseline, Lance and Recovery:
Behavioral Indicators of Infant Pain (BIIP) - total score
Heart Rate
Secondary outcomes (7)
Videotaped and Recorded at Baseline, Lance and Recovery:
Hand Movements
Sleep/Wake States
Samples taken at baseline, lance and recovery
Salivary Cortisol sample
Recorded before the breast feeding intervention and at 24 hours following:
Preterm Infant Breastfeeding Behavior Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- SickKids Foundation
- Investigators
- Liisa Holsti, PhD, OT, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175409
- Sponsor's protocol ID
- C05-0248
- Status last verified
- Apr 2011
- First submitted
- 11 Sep 2005
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Feeding Analgesia in Preterm Infants
- ClinicalTrials.gov ID
- NCT00175409
- Acronym / sponsor ID
- C05-0248
- Conditions
- Pain
- Keywords
- Pain Response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- SickKids Foundation
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Sep 2005 (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 effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
- When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
Detailed description
Research Method:
In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Blood collectionInfants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. |
| 2 | Active comparator | Procedure: Blood collectionInfants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection. |
Who may qualify
- Ages
- 3 days to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born between 30-36 weeks gestational age
- breastfeeding
- mother has fluent English
Key exclusion criteria (5 listed)
- CNS injury
- congenital anomaly
- active infection
- has had surgeries or analgesics/sedatives in last 72 hours
- history of maternal drug exposure
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 |
|---|---|---|
| Blood collectionFor the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. | Procedure or surgery | 1 |
| Blood collectionFor the feeding condition, infants will be held and then breast fed by their mother during the blood collection. | Procedure or surgery | 2 |
Primary outcome
Videotaped and recorded at Baseline, Lance and Recovery:
Behavioral Indicators of Infant Pain (BIIP) - total score
Heart Rate
7 secondary outcomes
Videotaped and Recorded at Baseline, Lance and Recovery:
Hand Movements
Sleep/Wake States
Samples taken at baseline, lance and recovery
Salivary Cortisol sample
Recorded before the breast feeding intervention and at 24 hours following:
Preterm Infant Breastfeeding Behavior Scale
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 12 Apr 2011.
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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.
Liisa Holsti, PhD, OT principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Blood collection in people with Pain, run by University of British Columbia at 2 sites 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 3 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 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Videotaped and recorded at Baseline, Lance and Recovery:. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2011.