Retinopathy of PrematurityPhase 4NCT00921544
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
A Phase 4 study testing Sucrose and Sterile water in people with Retinopathy of Prematurity, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial summary
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Sucrose and Sterile water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- < 1500 grams
- < 32 weeks
Who cannot join
- Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
- Infants where consent to participate was not obtained
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Coombe Women and Infants University Maternity Hospital
Dublin, Dublin, 8
About this study
Official title: Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Sucrose, Sterile water
- Keywords
- ROP, sucrose, pain
- Medical subject headings
- Retinopathy of Prematurity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseOther
Also called Sweeties
0.2 ml sucrose 24% given by mouth using a syringe and pacifier
Sterile waterOther
Sterile water administered 2 mins prior to eye exam
| Study group | Role | What they receive |
|---|---|---|
| Oral Sucrose | Active comparator | Oral sucrose administered 2 mins prior to eye exam Receives: Other: Sucrose |
| Sterile water | Placebo comparator | 0.2 mls of sterile water Receives: Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain profile score as assessed by NPASS
Measured: Scores assessed 3 months following completion of study
Secondary outcomes (1)
Number of adverse events
Measured: Assessed 3 months following completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eugene Dempsey, MD, FRCPI, Study director, Coombe Women and Infants University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921544
- Sponsor's protocol ID
- Coombesucrose
- Status last verified
- Jun 2009
- First submitted
- 10 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00921544
- Acronym / sponsor ID
- Coombesucrose
- Conditions
- Retinopathy of Prematurity
- Keywords
- ROP, sucrose, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Jun 2009 (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.
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Sucrose | Active comparator | Other: SucroseOral sucrose administered 2 mins prior to eye exam |
| Sterile water | Placebo comparator | Other: Sterile water0.2 mls of sterile water |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- < 1500 grams
- < 32 weeks
Key exclusion criteria (2 listed)
- Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
- Infants where consent to participate was not obtained
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 |
|---|---|---|
| SucroseAlso: Sweeties0.2 ml sucrose 24% given by mouth using a syringe and pacifier | Other | Oral Sucrose |
| Sterile waterSterile water administered 2 mins prior to eye exam | Other | Sterile water |
Primary outcome
Pain profile score as assessed by NPASS
Time frame: Scores assessed 3 months following completion of study
1 secondary outcome
Number of adverse events
Time frame: Assessed 3 months following completion
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 16 Jun 2009.
Related trials for Retinopathy of Prematurity
RecruitingObservational study
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Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
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Imaging Retinal Vasculature in Infant Eyes
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Safety, PK and PD of FLQ-101 in Premature Neonates
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Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
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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.
Eugene Dempsey, MD, FRCPI study director
Coombe Women and Infants University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sucrose and Sterile water in people with Retinopathy of Prematurity, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
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 2 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 16 Jun 2009. 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 Ireland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 profile score as assessed by NPASS (time frame: Scores assessed 3 months following completion of study). 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 16 Jun 2009.