Neonatal Procedural Pain ResponseCComforTNCT00917631
Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
A study testing Co-bedding (caring for twins in the same incubator) in people with Neonatal Procedural Pain Response, run by IWK Health Centre at 1 site in Canada.
Trial summary
A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Procedural Pain Response
- What is being tested?
- Co-bedding (caring for twins in the same incubator)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Sep 2012
- Phase
- Interventional
- 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
- All medically stable twin infants admitted to the NICU who are:
- Free from infection; and
- Breathing room air or receiving oxygen via nasal prongs.
- Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.
Who cannot join
- Weigh less than 1000 grams;
- Receiving ventilator support;
- Have chest tubes or umbilical catheter in situ;
- Have major congenital anomalies or chromosomal aberrations; OR
- If only one of the twins require overhead phototherapy.
Trial locations and contacts
1 site in 1 country.
About this study
A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.
- Conditions
- Neonatal Procedural Pain Response
- Being tested
- Co-bedding (caring for twins in the same incubator)
- Keywords
- Co-bedding, Procedural pain, Twin, Comfort, RCT
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-bedding (caring for twins in the same incubator)Procedure or surgery
Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding.
Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary.
Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Co-bedding | Experimental | Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding.
Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary.
Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes). Receives: Procedure: Co-bedding (caring for twins in the same incubator) |
| Standard care | No intervention | For infants who are randomized to receive standard care, the twin pair will remain in separate incubators as per current NICU policy. The infant will be nested in boundaries consistent with neonatal care practices. The heelstick may occur at any time following randomization (within 10 days) to maintain consistency between groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response(Premature Infant Pain Profile (PIPP)
Measured: Baseline until completion of heelstick
Secondary outcomes (5)
Recovery
Measured: The length of time for heart rate and oxygen saturation to return to normal (baseline).
Vagal tone
Measured: Baseline until completion of heelstick
Hormonal stress response (Cortisol)
Measured: Baseline and 20 minutes post heelstick
Frequency of 24% sucrose administration
Measured: Baseline to completion of the heelstick
The response of the co-twin not receiving the painful procedure
Measured: Baseline to completion of the heelstick
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal Procedural Pain ResponseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marsha Campbell-Yeo, IWK Health Centre
- Investigators
- Marsha L Campbell-Yeo, MN NNP-BC PhDc, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917631
- Sponsor's protocol ID
- #4382
- Acronym
- CComforT
- Status last verified
- Sep 2016
- First submitted
- 8 Jun 2009
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ, Walker CD. Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial. Clin J Pain. 2014 Jul;30(7):598-604. doi: 10.1097/AJP.0000000000000015.
PubMed 24300226Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ. Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial. Pediatrics. 2012 Sep;130(3):500-6. doi: 10.1542/peds.2012-0010. Epub 2012 Aug 27.
PubMed 22926182Campbell-Yeo ML, Johnston CC, Joseph K, Feeley NL, Chambers CT, Barrington KJ. Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial). BMC Pediatr. 2009 Dec 11;9:76. doi: 10.1186/1471-2431-9-76.
PubMed 20003351
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
- ClinicalTrials.gov ID
- NCT00917631
- Acronym / sponsor ID
- CComforT / #4382
- Conditions
- Neonatal Procedural Pain Response
- Keywords
- Co-bedding, Procedural pain, Twin, Comfort, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jun 2009 (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.
A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-bedding | Experimental | Procedure: Co-bedding (caring for twins in the same incubator)Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding. Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary. Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes). |
| Standard care | No intervention | –For infants who are randomized to receive standard care, the twin pair will remain in separate incubators as per current NICU policy. The infant will be nested in boundaries consistent with neonatal care practices. The heelstick may occur at any time following randomization (within 10 days) to maintain consistency between groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All medically stable twin infants admitted to the NICU who are:
- Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.
Key exclusion criteria (5 listed)
- Weigh less than 1000 grams;
- Receiving ventilator support;
- Have chest tubes or umbilical catheter in situ;
- Have major congenital anomalies or chromosomal aberrations; OR
- If only one of the twins require overhead phototherapy.
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 |
|---|---|---|
| Co-bedding (caring for twins in the same incubator)Twin infants will be placed together in a Incubator or crib lying side-by-side. Twins will be diaper clad and nested together in boundaries consistent with neonatal care practices. All infants will have cardio-respiratory monitoring while co-bedding. Infants in the co-bedding group be co-bedded for no less than 24 hours prior to heelstick to allow for stabilization following transfer. The heelstick being studied will occur no greater than 10 days following initiation of co-bedding. Duration of co-bedding will be recorded and controlled for in the analysis if necessary. Monitoring and video-tape recording will take approximately 20-30 minutes per participant - a baseline period (5-10 minutes prior to heel stick), warming (3 minutes), heel stick (2-5 minutes), and recovery phase (approximately 10 minutes). | Procedure or surgery | Co-bedding |
Primary outcome
Pain response(Premature Infant Pain Profile (PIPP)
Time frame: Baseline until completion of heelstick
5 secondary outcomes
Recovery
Time frame: The length of time for heart rate and oxygen saturation to return to normal (baseline).
Vagal tone
Time frame: Baseline until completion of heelstick
Hormonal stress response (Cortisol)
Time frame: Baseline and 20 minutes post heelstick
Frequency of 24% sucrose administration
Time frame: Baseline to completion of the heelstick
The response of the co-twin not receiving the painful procedure
Time frame: Baseline to completion of the heelstick
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 2 Sep 2016.
- Derived from this study: PubMed 24300226Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ, Walker CD. Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial. Clin J Pain. 2014 Jul;30(7):598-604. doi: 10.1097/AJP.0000000000000015.
- Derived from this study: PubMed 22926182Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ. Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial. Pediatrics. 2012 Sep;130(3):500-6. doi: 10.1542/peds.2012-0010. Epub 2012 Aug 27.
- Derived from this study: PubMed 20003351Campbell-Yeo ML, Johnston CC, Joseph K, Feeley NL, Chambers CT, Barrington KJ. Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial). BMC Pediatr. 2009 Dec 11;9:76. doi: 10.1186/1471-2431-9-76.
Related trials for Neonatal Procedural Pain Response
Not yet recruiting
Crochet Octopus in Reducing Procedural Pain During Heel Lance in Preterm Neonates
Preterm Neonates, Heel Lance Procedures
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.
Marsha L Campbell-Yeo, MN NNP-BC PhDc principal investigator
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 study testing Co-bedding (caring for twins in the same incubator) in people with Neonatal Procedural Pain Response, 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 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 2 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.
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?
Pain response(Premature Infant Pain Profile (PIPP) (time frame: Baseline until completion of heelstick). 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 NCT00917631, which also lists 3 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 2 Sep 2016.