Infant, PrematurePhase 2NCT00218946
Nasogastric Tube in Premature Babies - Pain and Treatment
A Phase 2 study testing Sucrose, Pacifier and sterile water in people with Infant, Premature, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted? Read more about this study
- Who is it for?
- Ages 3 days to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Sucrose, Pacifier and sterile water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Aug 2007
- Phase
- Phase 2
- 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 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 28 - 32 weeks gestational weeks
- not on mechanical ventilation
Who cannot join
- high risk group regarding cerebral prognosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?
Read the detailed description
A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.
- Conditions
- Infant, Premature
- Being tested
- Sucrose, Pacifier, sterile water
- Keywords
- pain, infant, premature, intubation, gastrointestinal, Neonatal nursing
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDrug
30 % sucrose
PacifierDevice
sterile waterOther
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | no fluid, no pacifier |
| water | Experimental | water, no pacifier Receives: Other: sterile water |
| sucrose | Experimental | Sucrose, no pacifier Receives: Drug: Sucrose |
| pacifier | Experimental | No fluid, pacifier Receives: Device: Pacifier |
| water and pacifier | Experimental | water, pacifier Receives: Device: Pacifier |
| sucrose and pacifier | Experimental | sucrose, pacifier Receives: Drug: Sucrose; Device: Pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured on PIPP (Premature Infant Pain Profile) scale
Measured: 4 week to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 2
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Eirik Skogvoll, MD, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218946
- Sponsor's protocol ID
- NISE-2005-1
- Status last verified
- Apr 2015
- First submitted
- 20 Sep 2005
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
PubMed 8722730Kristoffersen L, Skogvoll E, Hafstrom M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. doi: 10.1542/peds.2010-3438. Epub 2011 May 2.
PubMed 21536607
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
- ClinicalTrials.gov ID
- NCT00218946
- Acronym / sponsor ID
- NISE-2005-1
- Conditions
- Infant, Premature
- Keywords
- pain, infant, premature, intubation, gastrointestinal, Neonatal nursing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 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.
Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?
Detailed description
A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –no fluid, no pacifier |
| water | Experimental | Other: sterile waterwater, no pacifier |
| sucrose | Experimental | Drug: SucroseSucrose, no pacifier |
| pacifier | Experimental | Device: PacifierNo fluid, pacifier |
| water and pacifier | Experimental | Device: Pacifierwater, pacifier |
| sucrose and pacifier | Experimental | Drug: Sucrose, Device: Pacifiersucrose, pacifier |
Who may qualify
- Ages
- 3 days to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 28 - 32 weeks gestational weeks
- not on mechanical ventilation
Key exclusion criteria (1 listed)
- high risk group regarding cerebral prognosis
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 |
|---|---|---|
| Sucrose30 % sucrose | Drug | sucrose, sucrose and pacifier |
| Pacifier | Device | pacifier, sucrose and pacifier, water and pacifier |
| sterile water | Other | water |
Primary outcome
Pain measured on PIPP (Premature Infant Pain Profile) scale
Time frame: 4 week to complete
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 8 Apr 2015.
- Background: PubMed 8722730Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
- Results publication: PubMed 21536607Kristoffersen L, Skogvoll E, Hafstrom M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. doi: 10.1542/peds.2010-3438. Epub 2011 May 2.
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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.
Eirik Skogvoll, MD, PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucrose, Pacifier and sterile water in people with Infant, Premature, run by Norwegian University of Science and Technology 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 2 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 8 Apr 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain measured on PIPP (Premature Infant Pain Profile) scale (time frame: 4 week to complete). 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 NCT00218946, which also lists 2 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 8 Apr 2015.