Infant, NewbornPhase 2/3STOP-ROPNCT01203436
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
A Phase 2/3 study testing Supplemental Oxygen Management and Conventional Oxygen Management in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 9 sites in United States.
Trial summary
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- What is being tested?
- Supplemental Oxygen Management and Conventional Oxygen Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 1994to Mar 1999
- Phase
- Phase 2/3
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
- Median pulse oxygen saturation <94% in room air
- Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator
Who cannot join
- No fatal congenital anomaly or congenital eye anomaly
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30303
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
Indiana University
Indianapolis, Indiana, 46202
University of Tennessee
Memphis, Tennessee, 38163
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
Read the detailed description
Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.
This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Blindness
- Being tested
- Supplemental Oxygen Management, Conventional Oxygen Management
- Keywords
- NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity
- Medical subject headings
- Premature Birth, Retinopathy of Prematurity, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Oxygen ManagementProcedure or surgery
Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.
Conventional Oxygen ManagementProcedure or surgery
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Oxygen | Experimental | Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Receives: Procedure: Supplemental Oxygen Management |
| Conventional Oxygen | Active comparator | Conventional oxygenation at a pulse oximetry target of 89% to 94%. Receives: Procedure: Conventional Oxygen Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
Measured: 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startFeb 1994
- Primary completionMar 1999
- Study completionMar 1999
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 Infant, NewbornStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), National Eye Institute (NEI), National Institute of Nursing Research (NINR), Delta Gamma Sorority, Rhea and Raymond White, Research to Prevent Blindness
- Investigators
- Dale L. Phelps, MD, Study director, University of RochesterNeal L. Oden, PhD, Principal investigator, The Emmes Company, LLCCynthia Cole, MD, Principal investigator, Tufts Medical CenterRichard E. McClead, MD, Principal investigator, Ohio State UniversityAlan R. Spitzer, MD, Study director, Thomas Jefferson UniversityJ. David Bradford, MD, Principal investigator, Arkansas Childrens HospitalCharles C. Barr, MD, Principal investigator, University of LouisvilleWilliam Oh, MD, Principal investigator, Brown University, Womens and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203436
- Sponsor's protocol ID
- NICHD-NRN-0010
- Other IDs
- U10HD027904, U10HD027851, U10HD027856, U10HD027880, U10HD027853, U10HD021415, U10HD040689, U10HD021385
- Acronym
- STOP-ROP
- Status last verified
- Jun 2015
- First submitted
- 15 Sep 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.
PubMed 10654946
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT01203436
- Acronym / sponsor ID
- STOP-ROP / NICHD-NRN-0010
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Blindness
- Keywords
- NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), National Eye Institute (NEI), National Institute of Nursing Research (NINR), Delta Gamma Sorority, Rhea and Raymond White, Research to Prevent Blindness
- Study start
- Feb 1994
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 1999 (actual)
- First posted
- 16 Sep 2010 (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 purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
Detailed description
Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.
This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental Oxygen | Experimental | Procedure: Supplemental Oxygen ManagementSupplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. |
| Conventional Oxygen | Active comparator | Procedure: Conventional Oxygen ManagementConventional oxygenation at a pulse oximetry target of 89% to 94%. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
- Median pulse oxygen saturation <94% in room air
- Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator
Key exclusion criteria (1 listed)
- No fatal congenital anomaly or congenital eye anomaly
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 |
|---|---|---|
| Supplemental Oxygen ManagementSupplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints. | Procedure or surgery | Supplemental Oxygen |
| Conventional Oxygen ManagementConventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation. | Procedure or surgery | Conventional Oxygen |
Primary outcome
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
Time frame: 3 months of age
Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
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 Jun 2015.
- Results publication: PubMed 10654946Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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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.
Dale L. Phelps, MD study director
University of Rochester
Neal L. Oden, PhD principal investigator
The Emmes Company, LLC
Cynthia Cole, MD principal investigator
Tufts Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Supplemental Oxygen Management and Conventional Oxygen Management in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 9 sites in United States.
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 3 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 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 combined 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.
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?
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?
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery (time frame: 3 months of age). 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 NCT01203436, 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 8 Jun 2015.