Iron and Retinopathy of Prematurity (ROP)

NCT05133999 | Completed

• 2 other identifiers: APHP2112332021-A02182
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Retinopathy of Prematurity

Keywords

retinopathy; prematurity; ROP; Iron and transferrin; Preterm infants

Outcome Measures

Primary Outcomes (2)

• ROP screening

  Presence of ROP development (any stage / any zone in at least one eye) during follow-up.

  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

  at 1 week of life

Secondary Outcomes (7)

• Levels of iron

  at birth, 2, 3, and 4 weeks of life

• Levels of transferrin

  at birth, 2, 3, and 4 weeks of life

• Levels of ferritin

  at birth, 2, 3, and 4 weeks of life

• ROP's highest stage

  during follow-up about 5 months, up to 45 weeks' PMA

• Need of treatment for ROP

  during follow-up about 5 months, up to 45 weeks' PMA

Study Arms (1)

Preterm infants

infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birth weight

Biological: Plasma determination of iron, transferrin and ferritin; Other: Fundus Examination by wide field digital imaging camera (PanocamTM camera)

Interventions

Plasma determination of iron, transferrin and ferritin BIOLOGICAL

Iron, transferrin and ferritin levels in plasma

Preterm infants

Fundus Examination by wide field digital imaging camera (PanocamTM camera) OTHER

ROP screening using wide field digital retinal imaging according to current recommendations.

Preterm infants

Eligibility Criteria

• Age: 24 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born at \<31 weeks' PMA or ≤1250 g of birth weight

You may qualify if:

• 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

You may not qualify if:

• Congenital malformation
• Life-threatening condition (not expected to survive more than a few days)
• Absence of health care protection.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation VISIO: collaborator
• Fondation Université de Paris: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity

Paris, 75014, France

Location

Ophtalmology department _ Necker Enfants Malades Hospital

Paris, 75015, France

Location

Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital

Paris, 75015, France

Location

Related Publications (12)

• 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.

  PMID: 29168313 BACKGROUND

• 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.

  PMID: 26548746 BACKGROUND

• 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.

  PMID: 23642047 BACKGROUND

• 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.

  PMID: 20811158 BACKGROUND

• 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.

  PMID: 29550819 BACKGROUND

• 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.

  PMID: 9208245 BACKGROUND

• 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.

  PMID: 11245995 BACKGROUND

• 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.

  PMID: 9386655 BACKGROUND

• 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.

  PMID: 11320046 BACKGROUND

• 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.

  PMID: 30662950 BACKGROUND

• 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.

  PMID: 14595040 BACKGROUND

• 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.

  PMID: 26557385 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity; Retinal Diseases; Premature Birth

Interventions

Transferrin; Ferritins

Condition Hierarchy (Ancestors)

Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Beta-Globulins; Serum Globulins; Transferrins; Iron-Binding Proteins; Carrier Proteins; Globulins; Metalloproteins

Study Officials

• Alejandra DARUICH, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Elsa KERMOVANT, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 24, 2021
• Study Start: April 28, 2022
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)