Retinopathy of PrematurityROPNCT00648687
Pain Response During Examination for Retinopathy of Prematurity
A study testing suck 12.5% dextrose in water 5 minutes before the procedure in people with Retinopathy of Prematurity, run by National Bioethics Commission of Brazil at 1 site in Brazil.
Trial summary
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). Read more about this study
- Who is it for?
- Ages 5 weeks to 6 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- suck 12.5% dextrose in water 5 minutes before the procedure
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Jun 2010
- 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 5 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
Who cannot join
- the ones that died before 6 weeks old
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.
- Conditions
- Retinopathy of Prematurity
- Being tested
- suck 12.5% dextrose in water 5 minutes before the procedure
- Keywords
- prematurity, retinopathy of prematurity, pain, very low birth weight infants
- Medical subject headings
- Retinopathy of Prematurity, Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suck 12.5% dextrose in water 5 minutes before the procedureBehavioural
Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | this group will receive oral water and glucose prior to eye exam Receives: Behavioral: suck 12.5% dextrose in water 5 minutes before the procedure |
| II | No intervention | this group is the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain secondary to eye examination
Measured: 2 minutes after the exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Bioethics Commission of Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Renato S Procianoy, MD,PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648687
- Sponsor's protocol ID
- HCPA 07437
- Acronym
- ROP
- Status last verified
- Sep 2009
- First submitted
- 14 Mar 2008
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Costa MC, Eckert GU, Fortes BG, Fortes Filho JB, Silveira RC, Procianoy RS. Oral glucose for pain relief during examination for retinopathy of prematurity: a masked randomized clinical trial. Clinics (Sao Paulo). 2013;68(2):199-204. doi: 10.6061/clinics/2013(02)oa13.
PubMed 23525316
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT00648687
- Acronym / sponsor ID
- ROP / HCPA 07437
- Conditions
- Retinopathy of Prematurity
- Keywords
- prematurity, retinopathy of prematurity, pain, very low birth weight infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Bioethics Commission of BrazilUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Apr 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 infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: suck 12.5% dextrose in water 5 minutes before the procedurethis group will receive oral water and glucose prior to eye exam |
| II | No intervention | –this group is the control group. |
Who may qualify
- Ages
- 5 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
Key exclusion criteria (1 listed)
- the ones that died before 6 weeks old
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 |
|---|---|---|
| suck 12.5% dextrose in water 5 minutes before the procedureNewborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP | Behavioural | I |
Primary outcome
Pain secondary to eye examination
Time frame: 2 minutes after the exam
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 22 Jul 2010.
- Derived from this study: PubMed 23525316Costa MC, Eckert GU, Fortes BG, Fortes Filho JB, Silveira RC, Procianoy RS. Oral glucose for pain relief during examination for retinopathy of prematurity: a masked randomized clinical trial. Clinics (Sao Paulo). 2013;68(2):199-204. doi: 10.6061/clinics/2013(02)oa13.
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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.
Renato S Procianoy, MD,PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suck 12.5% dextrose in water 5 minutes before the procedure in people with Retinopathy of Prematurity, run by National Bioethics Commission of Brazil at 1 site in Brazil.
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 22 Jul 2010. 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 Brazil. 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?
Pain secondary to eye examination (time frame: 2 minutes after the exam). 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 NCT00648687, which also lists 1 linked publication.
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 Jul 2010.