Retinopathy of PrematurityPhase 3NCT06067958
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
A Phase 3 study testing Dexmedetomidine and Saline in people with Retinopathy of Prematurity and Dexmedetomidine, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not… Read more about this study
- Who is it for?
- Ages 4 weeks and older
- Conditions the study is for
- Retinopathy of Prematurity, Dexmedetomidine
- What is being tested?
- Dexmedetomidine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Dec 2023to Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
- Informed consent signed by one of the parents
Who cannot join
- Invasive ventilation at the time of the eye assessment
- Multiple congenital anomalies
- Chromosomal / genetic anomalies
- Infant received a sedative drug in last 5 days
- Eye examination for reasons other than retinopathy of prematurity screening
- Attending physician deemed the patient not stable enough
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Be’er Ya‘aqov, Center, 7033001
Sagee Nissimov, MD, 97289779080, sageen@shamir.gov.il
Sagee Nissimov, MD
About this study
Official title: Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.
Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.
Read more
The main questions it aims to answer are:
- Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).
- Does dexmedetomidine cause more adverse effects than placebo.
In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.
- Conditions
- Retinopathy of Prematurity, Dexmedetomidine
- Being tested
- Dexmedetomidine, Saline
- Keywords
- Retinopathy of Prematurity, Dexmedetomidine, Pain, Analgesia, Premature Infant Pain Profile - Revised
- Medical subject headings
- Retinopathy of Prematurity, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
SalineDrug
Intranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premature Infant Pain Profile: Revised, at peak
The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants <28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.
Every participant will be assessed using video recordings which will start 5 minutes before the administration of oral sucrose 24% and will continue until 5 minutes after the removal of the eyelid retractor.
The primary outcome will be the PIPP-R score one minute after the insertion of the retractor.
Measured: PIPP-R score will be assessed 60 seconds after the insertion of the retractor
Secondary outcomes (7)
The Premature Infant Pain Profile: Revised, 5 minutes
The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants <28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.
For this secondary outcome, PIPP-R score 5 minutes after the insertion of the retractor will be assessed.
Measured: 5 minutes after the insertion of the retractor
The Premature Infant Pain Profile: Revised, at completion
The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants <28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.
For this secondary outcome, PIPP-R score 2 minutes after the after the removal the retractors will be assessed.
Measured: 2 minutes after the removal the retractors
Apnea
Number of apneas or desaturations < 90%
Measured: From time 0 until 5 hours after the examination
Bradycardia
Number of bradycardias, defined as a drop of 20% from baseline heart rate
Measured: From time 0 until 5 hours after the examination
Heart rate
The average heart rate of the infant
Measured: Assessed every hour from time 0 until 5 hours after the examination
Duration of examination
The time between the insertion and the removal of the retractor
Measured: Up to 30 minutes
Percent of crying time
The percent of time in which the participant cried during the video recording
Measured: The duration of the video recording (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start11 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sagee Nissimov, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067958
- Sponsor's protocol ID
- 0096-23-ASF
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wood EH, Chang EY, Beck K, Hadfield BR, Quinn AR, Harper CA 3rd. 80 Years of vision: preventing blindness from retinopathy of prematurity. J Perinatol. 2021 Jun;41(6):1216-1224. doi: 10.1038/s41372-021-01015-8. Epub 2021 Mar 5.
PubMed 33674712Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.
PubMed 34247850Nayak R, Nagaraj KN, Gururaj G. Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water. Indian J Pediatr. 2020 May;87(5):353-358. doi: 10.1007/s12098-020-03182-6. Epub 2020 Jan 27.
PubMed 31989459Mitchell AJ, Green A, Jeffs DA, Roberson PK. Physiologic effects of retinopathy of prematurity screening examinations. Adv Neonatal Care. 2011 Aug;11(4):291-7. doi: 10.1097/ANC.0b013e318225a332.
PubMed 22123352Padhi TR, Sareen D, Pradhan L, Jalali S, Sutar S, Das T, Modi RR, Behera UC. Evaluation of retinopathy of prematurity screening in reverse Kangaroo Mother Care: a pilot study. Eye (Lond). 2015 Apr;29(4):505-8. doi: 10.1038/eye.2014.340. Epub 2015 Jan 23.
PubMed 25613847Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.
PubMed 24866853Walker SM. Long-term effects of neonatal pain. Semin Fetal Neonatal Med. 2019 Aug;24(4):101005. doi: 10.1016/j.siny.2019.04.005. Epub 2019 Apr 5.
PubMed 30987942Nesargi SV, Nithyanandam S, Rao S, Nimbalkar S, Bhat S. Topical anesthesia or oral dextrose for the relief of pain in screening for retinopathy of prematurity: a randomized controlled double-blinded trial. J Trop Pediatr. 2015 Feb;61(1):20-4. doi: 10.1093/tropej/fmu058. Epub 2014 Nov 5.
PubMed 25376189Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Ann Pharmacother. 2005 May;39(5):829-33. doi: 10.1345/aph.1E476. Epub 2005 Mar 29.
PubMed 15797982Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis. Pediatrics. 2018 Jul;142(1):e20180401. doi: 10.1542/peds.2018-0401. Epub 2018 Jun 1.
PubMed 29858451Dempsey E, McCreery K. Local anaesthetic eye drops for prevention of pain in preterm infants undergoing screening for retinopathy of prematurity. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD007645. doi: 10.1002/14651858.CD007645.pub2.
PubMed 21901708Campbell-Yeo M, Benoit B. Use of morphine before retinopathy of prematurity examinations. Lancet. 2018 Dec 15;392(10164):2521-2523. doi: 10.1016/S0140-6736(18)32324-9. Epub 2018 Nov 30. No abstract available.
PubMed 30509742Alselaimy R, Al Tawil L, Abouammoh MA. Anesthesia in retinopathy of prematurity. Saudi J Ophthalmol. 2022 Oct 14;36(3):251-259. doi: 10.4103/sjopt.sjopt_229_21. eCollection 2022 Jul-Sep.
PubMed 36276254Hartley C, Moultrie F, Hoskin A, Green G, Monk V, Bell JL, King AR, Buckle M, van der Vaart M, Gursul D, Goksan S, Juszczak E, Norman JE, Rogers R, Patel C, Adams E, Slater R. Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet. 2018 Dec 15;392(10164):2595-2605. doi: 10.1016/S0140-6736(18)31813-0. Epub 2018 Nov 30.
PubMed 30509743Sindhur M, Balasubramanian H, Srinivasan L, Kabra NS, Agashe P, Doshi A. Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial. J Perinatol. 2020 Jun;40(6):881-887. doi: 10.1038/s41372-020-0608-2. Epub 2020 Feb 13.
PubMed 32054982
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06067958
- Acronym / sponsor ID
- 0096-23-ASF
- Conditions
- Retinopathy of Prematurity, Dexmedetomidine
- Keywords
- Retinopathy of Prematurity, Dexmedetomidine, Pain, Analgesia, Premature Infant Pain Profile - Revised
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Oct 2023 (actual)
- 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.
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.
Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.
The main questions it aims to answer are:
- Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).
- Does dexmedetomidine cause more adverse effects than placebo.
In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineIntranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination |
| Placebo | Placebo comparator | Drug: SalineSaline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
- Informed consent signed by one of the parents
Key exclusion criteria (6 listed)
- Invasive ventilation at the time of the eye assessment
- Multiple congenital anomalies
- Chromosomal / genetic anomalies
- Infant received a sedative drug in last 5 days
- Eye examination for reasons other than retinopathy of prematurity screening
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 |
|---|---|---|
| DexmedetomidineIntranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume. | Drug | Dexmedetomidine |
| SalineIntranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume. | Drug | Placebo |
Primary outcome
The Premature Infant Pain Profile: Revised, at peak
Time frame: PIPP-R score will be assessed 60 seconds after the insertion of the retractor
The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants <28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort. Every participant will be assessed using video recordings which will start 5 minutes before the administration of oral sucrose 24% and will continue until 5 minutes after the removal of the eyelid retractor. The primary outcome will be the PIPP-R score one minute after the insertion of the retractor.
7 secondary outcomes
The Premature Infant Pain Profile: Revised, 5 minutes
Time frame: 5 minutes after the insertion of the retractor
The Premature Infant Pain Profile: Revised, at completion
Time frame: 2 minutes after the removal the retractors
Apnea
Time frame: From time 0 until 5 hours after the examination
Bradycardia
Time frame: From time 0 until 5 hours after the examination
Heart rate
Time frame: Assessed every hour from time 0 until 5 hours after the examination
Duration of examination
Time frame: Up to 30 minutes
Percent of crying time
Time frame: The duration of the video recording (up to 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 33674712Wood EH, Chang EY, Beck K, Hadfield BR, Quinn AR, Harper CA 3rd. 80 Years of vision: preventing blindness from retinopathy of prematurity. J Perinatol. 2021 Jun;41(6):1216-1224. doi: 10.1038/s41372-021-01015-8. Epub 2021 Mar 5.
- Background: PubMed 34247850Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.
- Background: PubMed 31989459Nayak R, Nagaraj KN, Gururaj G. Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water. Indian J Pediatr. 2020 May;87(5):353-358. doi: 10.1007/s12098-020-03182-6. Epub 2020 Jan 27.
- Background: PubMed 22123352Mitchell AJ, Green A, Jeffs DA, Roberson PK. Physiologic effects of retinopathy of prematurity screening examinations. Adv Neonatal Care. 2011 Aug;11(4):291-7. doi: 10.1097/ANC.0b013e318225a332.
- Background: PubMed 25613847Padhi TR, Sareen D, Pradhan L, Jalali S, Sutar S, Das T, Modi RR, Behera UC. Evaluation of retinopathy of prematurity screening in reverse Kangaroo Mother Care: a pilot study. Eye (Lond). 2015 Apr;29(4):505-8. doi: 10.1038/eye.2014.340. Epub 2015 Jan 23.
- Background: PubMed 24866853Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.
- Background: PubMed 30987942Walker SM. Long-term effects of neonatal pain. Semin Fetal Neonatal Med. 2019 Aug;24(4):101005. doi: 10.1016/j.siny.2019.04.005. Epub 2019 Apr 5.
- Background: PubMed 25376189Nesargi SV, Nithyanandam S, Rao S, Nimbalkar S, Bhat S. Topical anesthesia or oral dextrose for the relief of pain in screening for retinopathy of prematurity: a randomized controlled double-blinded trial. J Trop Pediatr. 2015 Feb;61(1):20-4. doi: 10.1093/tropej/fmu058. Epub 2014 Nov 5.
- Background: PubMed 15797982Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Ann Pharmacother. 2005 May;39(5):829-33. doi: 10.1345/aph.1E476. Epub 2005 Mar 29.
- Background: PubMed 29858451Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis. Pediatrics. 2018 Jul;142(1):e20180401. doi: 10.1542/peds.2018-0401. Epub 2018 Jun 1.
- Background: PubMed 21901708Dempsey E, McCreery K. Local anaesthetic eye drops for prevention of pain in preterm infants undergoing screening for retinopathy of prematurity. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD007645. doi: 10.1002/14651858.CD007645.pub2.
- Background: PubMed 30509742Campbell-Yeo M, Benoit B. Use of morphine before retinopathy of prematurity examinations. Lancet. 2018 Dec 15;392(10164):2521-2523. doi: 10.1016/S0140-6736(18)32324-9. Epub 2018 Nov 30. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Saline in people with Retinopathy of Prematurity and Dexmedetomidine, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 6 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sagee Nissimov, MD (97289779080, sageen@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Premature Infant Pain Profile: Revised, at peak (time frame: PIPP-R score will be assessed 60 seconds after the insertion of the retractor). 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 NCT06067958, which also lists 23 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 6 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.