Retinopathy of PrematurityFer-ROPNCT05133999
Iron and Retinopathy of Prematurity (ROP)
An observational study of Retinopathy of Prematurity, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity. Preterm infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Plasma determination of iron, transferrin and ferritin and Fundus Examination by wide field digital imaging camera (PanocamTM camera)
- How many people
- 175 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Apr 2022to 18 Aug 2025
- Phase
- Observational
- 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 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants born at <31 weeks' PMA or ≤1250 g of birth weight
Who may be able to join
- All infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birthweight
- Admitted at two neonatology departments (level III) from birth
- With non-opposition consent of two parents
Who cannot join
- Congenital malformation
- Life-threatening condition (not expected to survive more than a few days)
- Absence of health care protection.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity
Paris, 75014
Ophtalmology department _ Necker Enfants Malades Hospital
Paris, 75015
Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital
Paris, 75015
About this study
Official title: Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.
The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity.
Preterm infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Iron parameters in plasma will be measured during the first month of life. Retinopathy of prematurity (ROP) will be screened as currently recommended. The relationship between plasma iron parameters and ROP development and/or severity will be established.
Read the detailed description
The incidence of ROP, the main cause of vision impairment in children, is increasing parallel to the recent changes in practices targeting higher oxygen saturation in preterm babies in many countries following the publication of five trials that showed higher rates of death with lower oxygen saturations. The main risk factor for ROP development is oxygen excess. Oxygen contributes to the formation of reactive oxygen species and to lipid peroxidation which leads to vasoconstriction, vascular cytotoxicity, and arrest of vascular development causing ischemia of retinal neurons, thereby promoting the development of ROP.
90% of extremely low birth weight infants need red blood cell transfusions (RBCT) due to their immature erythropoiesis, frequent blood sampling and small circulating blood volume. RBCT are a major source of iron overload and ferritin plasma levels may remain elevated for several weeks after transfusions. It has been shown that blood transfusion is a risk factor of ROP in preterm infants. However, whether this relationship is mediated by an increased iron load remains controversial.
Only two studies, conducted before the 2000s, identified plasma iron overload as a risk factor for ROP. These studies with a limited number of patients, showed contradictory results, failing to draw a conclusion.
Excess iron worsens oxidative stress. Iron catalyzes the Fenton reaction which leads to the formation of reactive oxygen species. In addition a transferrin deficiency (the main iron chelator) has been suggested in premature infants. The oxidative stress observed in ROP could therefore be the consequence not only of oxygen therapy but also of iron overload.
The main objective of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity.
The secondary aims/objectives are :
- Determine whether low transferrin level in plasma is an independent risk factor for ROP development and severity.
- Determine whether iron parameters imbalance in plasma are a risk factor for other comorbidities in Preterm infants i.e.:
- 1) sepsis
- 2) severe bronchopulmonary dysplasia
- 3) necrotizing enterocolitis (stage 2 or 3)
- 4) cystic periventricular leukomalacia
- 5) grade III or IV intraventricular haemorrhage
Study duration will be 29 months, with an inclusion period of 24 months and a last visit for ROP evaluation at 45 week's post-menstrual age (PMA).
A total of 175 patients should be included: 35 with ROP and 140 without ROP.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Plasma determination of iron, transferrin and ferritin, Fundus Examination by wide field digital imaging camera (PanocamTM camera)
- Keywords
- retinopathy, prematurity, ROP, Iron and transferrin, Preterm infants
- Medical subject headings
- Retinopathy of Prematurity, Retinal Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma determination of iron, transferrin and ferritinBiological
Iron, transferrin and ferritin levels in plasma
Fundus Examination by wide field digital imaging camera (PanocamTM camera)Other
ROP screening using wide field digital retinal imaging according to current recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight Receives: Biological: Plasma determination of iron, transferrin and ferritin; Other: Fundus Examination by wide field digital imaging camera (PanocamTM camera) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROP screening
Presence of ROP development (any stage / any zone in at least one eye) during follow-up.
Measured: From 31 to 45 weeks' post menstrual age (PMA) [= (term + 4 weeks of life)].
Levels of transferrin saturation in plasma at 1 week of life
Blood dosage
Measured: at 1 week of life
Secondary outcomes (7)
Levels of iron
Blood dosage, in µmol/l
Measured: at birth, 2, 3, and 4 weeks of life
Levels of transferrin
Blood dosage, in g/l
Measured: at birth, 2, 3, and 4 weeks of life
Levels of ferritin
Blood dosage, in µg/l
Measured: at birth, 2, 3, and 4 weeks of life
ROP's highest stage
according to International Classification of Retinopathy of Prematury (ICROP3 classification)
Measured: during follow-up about 5 months, up to 45 weeks' PMA
Need of treatment for ROP
Laser, anti-VEGF injections, surgery
Measured: during follow-up about 5 months, up to 45 weeks' PMA
Number of each intervention
Number of each intervention if a treatment was needed
Measured: during follow-up about 5 months, up to 45 weeks' PMA
Death or presence of severe co-morbidities in preterm infant
death or presence of monitoring :
- severe bronchopulmonary dysplasia or 2) necrotizing enterocolitis (stage 2 or 3), or 3) cavitary periventricular leucomalacia or 4) intraventricular haemorrhage (grade III or IV).
Measured: At 36 weeks' PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start28 Apr 2022
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation VISIO, Fondation Université de Paris, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alejandra DARUICH, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisElsa KERMOVANT, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133999
- Sponsor's protocol ID
- APHP211233
- Other IDs
- 2021-A02182
- Acronym
- Fer-ROP
- Status last verified
- Oct 2025
- First submitted
- 2 Nov 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Verdier K, Ulla E, Lofgren S, Fernell E. Children with blindness - major causes, developmental outcomes and implications for habilitation and educational support: a two-decade, Swedish population-based study. Acta Ophthalmol. 2018 May;96(3):295-300. doi: 10.1111/aos.13631. Epub 2017 Nov 23.
PubMed 29168313Manley BJ, Kuschel CA, Elder JE, Doyle LW, Davis PG. Higher Rates of Retinopathy of Prematurity after Increasing Oxygen Saturation Targets for Very Preterm Infants: Experience in a Single Center. J Pediatr. 2016 Jan;168:242-244. doi: 10.1016/j.jpeds.2015.10.005. Epub 2015 Nov 6.
PubMed 26548746BOOST II United Kingdom Collaborative Group; BOOST II Australia Collaborative Group; BOOST II New Zealand Collaborative Group; Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.
PubMed 23642047Sapieha P, Joyal JS, Rivera JC, Kermorvant-Duchemin E, Sennlaub F, Hardy P, Lachapelle P, Chemtob S. Retinopathy of prematurity: understanding ischemic retinal vasculopathies at an extreme of life. J Clin Invest. 2010 Sep;120(9):3022-32. doi: 10.1172/JCI42142. Epub 2010 Sep 1.
PubMed 20811158Howarth C, Banerjee J, Aladangady N. Red Blood Cell Transfusion in Preterm Infants: Current Evidence and Controversies. Neonatology. 2018;114(1):7-16. doi: 10.1159/000486584. Epub 2018 Mar 16.
PubMed 29550819Hesse L, Eberl W, Schlaud M, Poets CF. Blood transfusion. Iron load and retinopathy of prematurity. Eur J Pediatr. 1997 Jun;156(6):465-70. doi: 10.1007/s004310050641.
PubMed 9208245Dani C, Reali MF, Bertini G, Martelli E, Pezzati M, Rubaltelli FF. The role of blood transfusions and iron intake on retinopathy of prematurity. Early Hum Dev. 2001 Apr;62(1):57-63. doi: 10.1016/s0378-3782(01)00115-3.
PubMed 11245995Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4. doi: 10.1016/s0022-3476(97)70058-1.
PubMed 9386655Hirano K, Morinobu T, Kim H, Hiroi M, Ban R, Ogawa S, Ogihara H, Tamai H, Ogihara T. Blood transfusion increases radical promoting non-transferrin bound iron in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 May;84(3):F188-93. doi: 10.1136/fn.84.3.f188.
PubMed 11320046Daruich A, Le Rouzic Q, Jonet L, Naud MC, Kowalczuk L, Pournaras JA, Boatright JH, Thomas A, Turck N, Moulin A, Behar-Cohen F, Picard E. Iron is neurotoxic in retinal detachment and transferrin confers neuroprotection. Sci Adv. 2019 Jan 9;5(1):eaau9940. doi: 10.1126/sciadv.aau9940. eCollection 2019 Jan.
PubMed 30662950Hellstrom A, Engstrom E, Hard AL, Albertsson-Wikland K, Carlsson B, Niklasson A, Lofqvist C, Svensson E, Holm S, Ewald U, Holmstrom G, Smith LE. Postnatal serum insulin-like growth factor I deficiency is associated with retinopathy of prematurity and other complications of premature birth. Pediatrics. 2003 Nov;112(5):1016-20. doi: 10.1542/peds.112.5.1016.
PubMed 14595040Luo XQ, Zhang CY, Zhang JW, Jiang JB, Yin AH, Guo L, Nie C, Lu XZ, Deng H, Zhang L. Identification of Iron Homeostasis Genes Dysregulation Potentially Involved in Retinopathy of Prematurity Pathogenicity by Microarray Analysis. J Ophthalmol. 2015;2015:584854. doi: 10.1155/2015/584854. Epub 2015 Oct 18.
PubMed 26557385
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.
- ClinicalTrials.gov ID
- NCT05133999
- Acronym / sponsor ID
- Fer-ROP / APHP211233
- Conditions
- Retinopathy of Prematurity
- Keywords
- retinopathy, prematurity, ROP, Iron and transferrin, Preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation VISIO, Fondation Université de Paris, URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 24 Nov 2021 (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.
The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity.
Preterm infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Iron parameters in plasma will be measured during the first month of life. Retinopathy of prematurity (ROP) will be screened as currently recommended. The relationship between plasma iron parameters and ROP development and/or severity will be established.
Detailed description
The incidence of ROP, the main cause of vision impairment in children, is increasing parallel to the recent changes in practices targeting higher oxygen saturation in preterm babies in many countries following the publication of five trials that showed higher rates of death with lower oxygen saturations. The main risk factor for ROP development is oxygen excess. Oxygen contributes to the formation of reactive oxygen species and to lipid peroxidation which leads to vasoconstriction, vascular cytotoxicity, and arrest of vascular development causing ischemia of retinal neurons, thereby promoting the development of ROP.
90% of extremely low birth weight infants need red blood cell transfusions (RBCT) due to their immature erythropoiesis, frequent blood sampling and small circulating blood volume. RBCT are a major source of iron overload and ferritin plasma levels may remain elevated for several weeks after transfusions. It has been shown that blood transfusion is a risk factor of ROP in preterm infants. However, whether this relationship is mediated by an increased iron load remains controversial.
Only two studies, conducted before the 2000s, identified plasma iron overload as a risk factor for ROP. These studies with a limited number of patients, showed contradictory results, failing to draw a conclusion.
Excess iron worsens oxidative stress. Iron catalyzes the Fenton reaction which leads to the formation of reactive oxygen species. In addition a transferrin deficiency (the main iron chelator) has been suggested in premature infants. The oxidative stress observed in ROP could therefore be the consequence not only of oxygen therapy but also of iron overload.
The main objective of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity.
The secondary aims/objectives are :
- Determine whether low transferrin level in plasma is an independent risk factor for ROP development and severity.
- Determine whether iron parameters imbalance in plasma are a risk factor for other comorbidities in Preterm infants i.e.:
- 1) sepsis
- 2) severe bronchopulmonary dysplasia
- 3) necrotizing enterocolitis (stage 2 or 3)
- 4) cystic periventricular leukomalacia
- 5) grade III or IV intraventricular haemorrhage
Study duration will be 29 months, with an inclusion period of 24 months and a last visit for ROP evaluation at 45 week's post-menstrual age (PMA).
A total of 175 patients should be included: 35 with ROP and 140 without ROP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Biological: Plasma determination of iron, transferrin and ferritin, Other: Fundus Examination by wide field digital imaging camera (PanocamTM camera)infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants born at <31 weeks' PMA or ≤1250 g of birth weight
Key inclusion criteria (3 listed)
- All infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birthweight
- Admitted at two neonatology departments (level III) from birth
- With non-opposition consent of two parents
Key exclusion criteria (3 listed)
- Congenital malformation
- Life-threatening condition (not expected to survive more than a few days)
- Absence of health care protection.
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 |
|---|---|---|
| Plasma determination of iron, transferrin and ferritinIron, transferrin and ferritin levels in plasma | Biological | Preterm infants |
| Fundus Examination by wide field digital imaging camera (PanocamTM camera)ROP screening using wide field digital retinal imaging according to current recommendations. | Other | Preterm infants |
Primary outcome
ROP screening
Time frame: From 31 to 45 weeks' post menstrual age (PMA) [= (term + 4 weeks of life)].
Presence of ROP development (any stage / any zone in at least one eye) during follow-up.
Levels of transferrin saturation in plasma at 1 week of life
Time frame: at 1 week of life
Blood dosage
7 secondary outcomes
Levels of iron
Time frame: at birth, 2, 3, and 4 weeks of life
Levels of transferrin
Time frame: at birth, 2, 3, and 4 weeks of life
Levels of ferritin
Time frame: at birth, 2, 3, and 4 weeks of life
ROP's highest stage
Time frame: during follow-up about 5 months, up to 45 weeks' PMA
Need of treatment for ROP
Time frame: during follow-up about 5 months, up to 45 weeks' PMA
Number of each intervention
Time frame: during follow-up about 5 months, up to 45 weeks' PMA
Death or presence of severe co-morbidities in preterm infant
Time frame: At 36 weeks' PMA
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 20 Nov 2025.
- Background: PubMed 29168313de Verdier K, Ulla E, Lofgren S, Fernell E. Children with blindness - major causes, developmental outcomes and implications for habilitation and educational support: a two-decade, Swedish population-based study. Acta Ophthalmol. 2018 May;96(3):295-300. doi: 10.1111/aos.13631. Epub 2017 Nov 23.
- Background: PubMed 26548746Manley BJ, Kuschel CA, Elder JE, Doyle LW, Davis PG. Higher Rates of Retinopathy of Prematurity after Increasing Oxygen Saturation Targets for Very Preterm Infants: Experience in a Single Center. J Pediatr. 2016 Jan;168:242-244. doi: 10.1016/j.jpeds.2015.10.005. Epub 2015 Nov 6.
- Background: PubMed 23642047BOOST II United Kingdom Collaborative Group; BOOST II Australia Collaborative Group; BOOST II New Zealand Collaborative Group; Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.
- Background: PubMed 20811158Sapieha P, Joyal JS, Rivera JC, Kermorvant-Duchemin E, Sennlaub F, Hardy P, Lachapelle P, Chemtob S. Retinopathy of prematurity: understanding ischemic retinal vasculopathies at an extreme of life. J Clin Invest. 2010 Sep;120(9):3022-32. doi: 10.1172/JCI42142. Epub 2010 Sep 1.
- Background: PubMed 29550819Howarth C, Banerjee J, Aladangady N. Red Blood Cell Transfusion in Preterm Infants: Current Evidence and Controversies. Neonatology. 2018;114(1):7-16. doi: 10.1159/000486584. Epub 2018 Mar 16.
- Background: PubMed 9208245Hesse L, Eberl W, Schlaud M, Poets CF. Blood transfusion. Iron load and retinopathy of prematurity. Eur J Pediatr. 1997 Jun;156(6):465-70. doi: 10.1007/s004310050641.
- Background: PubMed 11245995Dani C, Reali MF, Bertini G, Martelli E, Pezzati M, Rubaltelli FF. The role of blood transfusions and iron intake on retinopathy of prematurity. Early Hum Dev. 2001 Apr;62(1):57-63. doi: 10.1016/s0378-3782(01)00115-3.
- Background: PubMed 9386655Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4. doi: 10.1016/s0022-3476(97)70058-1.
- Background: PubMed 11320046Hirano K, Morinobu T, Kim H, Hiroi M, Ban R, Ogawa S, Ogihara H, Tamai H, Ogihara T. Blood transfusion increases radical promoting non-transferrin bound iron in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 May;84(3):F188-93. doi: 10.1136/fn.84.3.f188.
- Background: PubMed 30662950Daruich A, Le Rouzic Q, Jonet L, Naud MC, Kowalczuk L, Pournaras JA, Boatright JH, Thomas A, Turck N, Moulin A, Behar-Cohen F, Picard E. Iron is neurotoxic in retinal detachment and transferrin confers neuroprotection. Sci Adv. 2019 Jan 9;5(1):eaau9940. doi: 10.1126/sciadv.aau9940. eCollection 2019 Jan.
- Background: PubMed 14595040Hellstrom A, Engstrom E, Hard AL, Albertsson-Wikland K, Carlsson B, Niklasson A, Lofqvist C, Svensson E, Holm S, Ewald U, Holmstrom G, Smith LE. Postnatal serum insulin-like growth factor I deficiency is associated with retinopathy of prematurity and other complications of premature birth. Pediatrics. 2003 Nov;112(5):1016-20. doi: 10.1542/peds.112.5.1016.
- Background: PubMed 26557385Luo XQ, Zhang CY, Zhang JW, Jiang JB, Yin AH, Guo L, Nie C, Lu XZ, Deng H, Zhang L. Identification of Iron Homeostasis Genes Dysregulation Potentially Involved in Retinopathy of Prematurity Pathogenicity by Microarray Analysis. J Ophthalmol. 2015;2015:584854. doi: 10.1155/2015/584854. Epub 2015 Oct 18.
- 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. This study is not recruiting at the moment.
Alejandra DARUICH, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Elsa KERMOVANT, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 3 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
ROP screening (time frame: From 31 to 45 weeks' post menstrual age (PMA) [= (term + 4 weeks of life)].). The study lists 2 primary outcomes in all. 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 NCT05133999, which also lists 12 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 20 Nov 2025.