Iron and Retinopathy of Prematurity (ROP)

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Brief Title

Iron and Retinopathy of Prematurity (ROP)

Official Title

Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.

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.
    

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 Type

Observational


Primary Outcome

ROP screening

Secondary Outcome

 Levels of iron

Condition

Retinopathy of Prematurity

Intervention

Plasma determination of iron, transferrin and ferritin

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

175

Start Date

December 2021

Completion Date

May 2024

Primary Completion Date

May 2024

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Congenital malformation

          -  Life-threatening condition (not expected to survive more than a few days)

          -  Absence of health care protection.
      

Gender

All

Ages

24 Weeks - 31 Weeks

Accepts Healthy Volunteers

No

Contacts

Alejandra DARUICH, MD, PhD, +33-(0)1-44-38-19-69, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05133999

Organization ID

APHP211233

Secondary IDs

2021-A02182

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Fondation VISIO

Study Sponsor

Alejandra DARUICH, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

November 2021