Pain DetectionNCT00447824
Pain Detection and Interception in Neonates
A study testing Introduction of better conditions during blood sampling in people with Pain Detection and Pain Intervention, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Hypothesis: 1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample 2. Compare the effect of venous and capillary blood sample method Read more about this study
- Who is it for?
- Ages 31 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain Detection, Pain Intervention
- What is being tested?
- Introduction of better conditions during blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Nov 2009
- 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 31 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born gestation age 31-36
Who cannot join
- Infection, respiratory distress
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sorlandet Hospital SSHF
Kristiansand, Vest Agder, 4600
Liv Normann
Randi S Dahl
About this study
Official title: Pain Detection and Interception in Neonates During Blood Sampling
Hypothesis:
- May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
- Compare the effect of venous and capillary blood sample method
Read the detailed description
introducing the: Newborn Individualized Developmental Care and Assessment Program
- Conditions
- Pain Detection, Pain Intervention
- Being tested
- Introduction of better conditions during blood sampling
- Keywords
- Pain, Neonates, NIDCAP, Venous, Capillary
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction of better conditions during blood samplingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
value of Premature Infant Pain Profile
Heart rate
Saturation
Skin conductance changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain DetectionStudies 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
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Helse sor
- Investigators
- Knut G Hernes, Dr, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447824
- Sponsor's protocol ID
- S-06471a
- Status last verified
- Mar 2007
- First submitted
- 13 Mar 2007
- Last updated
- 15 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Detection and Interception in Neonates During Blood Sampling
- ClinicalTrials.gov ID
- NCT00447824
- Acronym / sponsor ID
- S-06471a
- Conditions
- Pain Detection, Pain Intervention
- Keywords
- Pain, Neonates, NIDCAP, Venous, Capillary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Helse sor
- Study start
- Mar 2007
- Study completion
- Nov 2009
- First posted
- 15 Mar 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.
Hypothesis:
- May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
- Compare the effect of venous and capillary blood sample method
Detailed description
introducing the: Newborn Individualized Developmental Care and Assessment Program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 31 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born gestation age 31-36
Key exclusion criteria (1 listed)
- Infection, respiratory distress
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 |
|---|---|---|
| Introduction of better conditions during blood sampling | Procedure or surgery | – |
Primary outcome
value of Premature Infant Pain Profile
Heart rate
Saturation
Skin conductance changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
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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.
Knut G Hernes, Dr study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introduction of better conditions during blood sampling in people with Pain Detection and Pain Intervention, run by Sorlandet Hospital HF at 1 site in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2007. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Knut G Hernes, Dr (+(47) 957 99999, drhernes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of Premature Infant Pain Profile. The study lists 4 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 15 Mar 2007.