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Exposure to Plasticisers in the Neonatal Intensive Care Unit

NCT05404815 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2024-08-19

No results posted yet for this study

Summary

Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition. While being in a critical developmental period, constant exposure to these invasive medical devices puts premature neonates at risk of plasticizers' potential toxicity. Despite novel regulations and development of alternative plasticizers (AP), reference to guide manufacturers and an overview of the prevailing exposure levels to DEHP or alternatives in the neonatal intensive care unit (NICU) are still missing. The three main objectives of this project are: (1) to assess current exposure to plasticizers in the NICU, (2) to identify the sources of exposure and (3) to study the resultant long-term health risk in premature neonates. These objectives are addressed in three work packages (WP). In work package 1, in vivo exposure of premature neonates to phthalates and alternative plasticizers is assessed by determining their metabolites in biological matrices (urine and hair). Work package 2 explores ex vivo leaching characteristics of different plasticizers from medical devices used in the NICU. Finally, Work package 3 studies the long-term neurocognitive and lung development in relation to plasticizer exposure in the NICU.

Conditions

  • Preterm Birth
  • Premature Birth
  • Neurodevelopmental Disorders
  • Pulmonary Disease
  • Bronchopulmonary Dysplasia
  • Harm Reduction
  • Environmental Exposure
  • Development, Infant

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Philippe G Jorens, MD, PhD · University Hospital, Antwerp

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404815 on ClinicalTrials.gov