Somatosensory DisordersNCT00503100
Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
An observational study of Somatosensory Disorders, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Somatosensory Disorders
- What is being tested?
- Thermal stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Jan 2014
- Phase
- Observational
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Four groups of 20 adolescents (aged 14 years or older), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.
Who may be able to join
- For all:
- Age 15-18
- Appropriate weight for gestational age (AGA)
- Informed consent signed by the parent
- Presence of one parent during the examination
- Premature groups:
Show all 13Show fewer
- Preterm-born (32-34 weeks of gestation)
- Admitted to the NICU (ventilated vs. non-ventilated)
- Full term groups:
- Completed 37 weeks of gestation Pain groups (premature and full term)
- Admitted to the NICU
- Mechanically-ventilated during the first week of life
- Mechanically-ventilated for at least 48 hours
Who cannot join
- Current use of analgesia
- A chronic illness with current medical treatment
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ben Gurion University of the Negev, Siaal research center for family medicine and primary care
Beersheba, 84105
About this study
Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life.
Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs.
Read more
Design: Case-control study.
Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.
Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.
- Conditions
- Somatosensory Disorders
- Being tested
- Thermal stimulation
- Keywords
- Pain, Preterm-Born Adolescents
- Medical subject headings
- Somatosensory Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stimulationDevice
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.
| Study group | Role | What they receive |
|---|---|---|
| NICU full-term early pain group | Not described Receives: Device: Thermal stimulation | |
| NICU premature early pain group | Not described Receives: Device: Thermal stimulation | |
| NICU premature control group | Not described Receives: Device: Thermal stimulation | |
| Soroka- full-term control group | Not described Receives: Device: Thermal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
Measured: During the test
Secondary outcomes (2)
Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel).
Measured: At time of the test
Pain threshold to tactile stimulation will be measured by using Von-Frey hairs
Measured: At time of the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Difficulties in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatosensory DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pesach Shvartzman, Soroka University Medical Center
- Investigators
- Pesach Shvartzman, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503100
- Sponsor's protocol ID
- SOR458107CTIL
- Status last verified
- May 2015
- First submitted
- 17 Jul 2007
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
- ClinicalTrials.gov ID
- NCT00503100
- Acronym / sponsor ID
- SOR458107CTIL
- Conditions
- Somatosensory Disorders
- Keywords
- Pain, Preterm-Born Adolescents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Jul 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.
Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life.
Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs.
Design: Case-control study.
Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.
Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NICU full-term early pain group | – | Device: Thermal stimulation |
| NICU premature early pain group | – | Device: Thermal stimulation |
| NICU premature control group | – | Device: Thermal stimulation |
| Soroka- full-term control group | – | Device: Thermal stimulation |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Four groups of 20 adolescents (aged 14 years or older), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.
Key inclusion criteria (13 listed)
- Age 15-18
- Appropriate weight for gestational age (AGA)
- Informed consent signed by the parent
- Presence of one parent during the examination
- Preterm-born (32-34 weeks of gestation)
Key exclusion criteria (3 listed)
- Current use of analgesia
- A chronic illness with current medical treatment
- Cognitive impairment
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 |
|---|---|---|
| Thermal stimulationCerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs. | Device | NICU full-term early pain group, NICU premature control group, NICU premature early pain group, Soroka- full-term control group |
Primary outcome
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
Time frame: During the test
2 secondary outcomes
Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel).
Time frame: At time of the test
Pain threshold to tactile stimulation will be measured by using Von-Frey hairs
Time frame: At time of the test
Results and safety
The study was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Pesach Shvartzman, MD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatosensory Disorders, run by Soroka University Medical Center at 1 site in Israel.
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 13 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: stopped early, as of the sponsor's last update on 21 May 2015. 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 Israel. 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 was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
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?
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). (time frame: During the test). 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 21 May 2015.