Infant, PrematureNCT01552993
Registration and Treatment of Pain During Eye Examination of Prematurity
A study testing paracetamol and sucrose in people with Infant, Premature and Retinopathy, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants. Read more about this study
- Who is it for?
- Ages 31 to 37 weeks
- Conditions the study is for
- Infant, Premature, Retinopathy
- What is being tested?
- paracetamol and sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2012to Oct 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 31 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants < 32 weeks of gestational age (< 31+6 weeks)
Who cannot join
- Infants with ongoing analgesic treatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.
Read the detailed description
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.
This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.
- Conditions
- Infant, Premature, Retinopathy
- Being tested
- paracetamol, sucrose
- Keywords
- prematurity, retinopathy, pain, acetaminophen
- Medical subject headings
- Premature Birth, Retinal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Paracetamol mixture 20 mg/kg + pacifier and glucose
sucroseDrug
pacifier and sucrose
| Study group | Role | What they receive |
|---|---|---|
| paracetamol | Experimental | Paracetamol mixture 20 mg/kg + pacifier and sucrose Receives: Drug: paracetamol |
| placebo | Placebo comparator | pacifier and sucrose only Receives: Drug: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers
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 posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: the chosen intervention was obviously ineffective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Hakon Bergseng, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552993
- Sponsor's protocol ID
- HB2012-02
- Status last verified
- Apr 2016
- First submitted
- 2 Mar 2012
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration and Treatment of Pain During Eye Examination of Prematurity
- ClinicalTrials.gov ID
- NCT01552993
- Acronym / sponsor ID
- HB2012-02
- Conditions
- Infant, Premature, Retinopathy
- Keywords
- prematurity, retinopathy, pain, acetaminophen
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the chosen intervention was obviously ineffective
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Mar 2012 (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.
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.
Detailed description
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.
This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Experimental | Drug: paracetamolParacetamol mixture 20 mg/kg + pacifier and sucrose |
| placebo | Placebo comparator | Drug: sucrosepacifier and sucrose only |
Who may qualify
- Ages
- 31 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants < 32 weeks of gestational age (< 31+6 weeks)
Key exclusion criteria (1 listed)
- Infants with ongoing analgesic treatment
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 |
|---|---|---|
| paracetamolParacetamol mixture 20 mg/kg + pacifier and glucose | Drug | paracetamol |
| sucrosepacifier and sucrose | Drug | placebo |
Primary outcome
pain
Time frame: 5 minutes
Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers
Results and safety
The study was stopped early (reason given: the chosen intervention was obviously ineffective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
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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.
Hakon Bergseng, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol and sucrose in people with Infant, Premature and Retinopathy, run by St. Olavs Hospital 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: stopped early, as of the sponsor's last update on 22 Apr 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 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. Some participants in this study may receive a placebo. 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: the chosen intervention was obviously ineffective). 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?
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 22 Apr 2016.