PainNCT00740298
Thermal Analgesia in Newborns
A study testing sucrose and warmth in people with Pain, run by University of Chicago at 1 site in United States.
Trial summary
Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later… Read more about this study
- Who is it for?
- Ages Up to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- sucrose and warmth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2008to 26 Apr 2018
- 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 Up to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants
Who cannot join
- unhealthy infants
Trial locations and contacts
1 site in 1 country.
About this study
Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.
- Conditions
- Pain
- Being tested
- sucrose, warmth
- Keywords
- infants, undergoing, vaccinations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroseOther
sweet taste
warmthOther
warmth
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sweet Taste Receives: Other: sucrose |
| 2 | Active comparator | warmth Receives: Other: warmth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased behavioral and physiologic indicators of pain
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study start1 Jul 2008
- Primary completion26 Apr 2018
- Study completion26 Apr 2018
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 ChicagoThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lawrence A Gray, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740298
- Sponsor's protocol ID
- 15480A
- Other IDs
- 5K23HD049452
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2008
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Analgesia in Newborns
- ClinicalTrials.gov ID
- NCT00740298
- Acronym / sponsor ID
- 15480A
- Conditions
- Pain
- Keywords
- infants, undergoing, vaccinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 22 Aug 2008 (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.
Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: sucroseSweet Taste |
| 2 | Active comparator | Other: warmthwarmth |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants
Key exclusion criteria (1 listed)
- unhealthy infants
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 |
|---|---|---|
| sucrosesweet taste | Other | 1 |
| warmthwarmth | Other | 2 |
Primary outcome
Decreased behavioral and physiologic indicators of pain
Time frame: 5 minutes
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 26 Apr 2023.
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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.
Lawrence A Gray, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose and warmth in people with Pain, run by University of Chicago at 1 site in United States.
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: finished, as of the sponsor's last update on 26 Apr 2023. 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 United States. 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?
Decreased behavioral and physiologic indicators of pain (time frame: 5 minutes). 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 26 Apr 2023.