Study Results
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Basic Information
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COMPLETED
175 participants
OBSERVATIONAL
2022-04-28
2025-08-18
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm infants
infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birth weight
Plasma determination of iron, transferrin and ferritin
Iron, transferrin and ferritin levels in plasma
Fundus Examination by wide field digital imaging camera (PanocamTM camera)
ROP screening using wide field digital retinal imaging according to current recommendations.
Interventions
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Plasma determination of iron, transferrin and ferritin
Iron, transferrin and ferritin levels in plasma
Fundus Examination by wide field digital imaging camera (PanocamTM camera)
ROP screening using wide field digital retinal imaging according to current recommendations.
Eligibility Criteria
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Inclusion Criteria
* Admitted at two neonatology departments (level III) from birth
* With non-opposition consent of two parents
Exclusion Criteria
* Life-threatening condition (not expected to survive more than a few days)
* Absence of health care protection.
24 Weeks
31 Weeks
ALL
No
Sponsors
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Fondation VISIO
UNKNOWN
Fondation Université de Paris
UNKNOWN
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Alejandra DARUICH, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Elsa KERMOVANT, MD, PhD
Role: STUDY_CHAIR
Assistance Publique - Hôpitaux de Paris
Locations
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Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity
Paris, , France
Ophtalmology department _ Necker Enfants Malades Hospital
Paris, , France
Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital
Paris, , France
Countries
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References
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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.
Manley 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.
BOOST 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.
Sapieha 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.
Howarth 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.
Hesse 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.
Dani 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.
Inder 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.
Hirano 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.
Daruich 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.
Hellstrom 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.
Luo 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.
Other Identifiers
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2021-A02182
Identifier Type: OTHER
Identifier Source: secondary_id
APHP211233
Identifier Type: -
Identifier Source: org_study_id
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