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NCT Number: NCT05404815

Exposure to Plasticisers in the Neonatal Intensive Care Unit

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.

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Key information

Conditions

Preterm Birth Behavior Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Development, Infant Environmental Exposure Female Urogenital Diseases and Pregnancy Complications Harm Reduction Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Mental Disorders Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Disease Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital - Neonatal Intensive Care Unit

Edegem, Antwerp, 2650, Belgium

About this study

RESEARCH HYPOTHESIS: Leaching of plasticizers (DEHP and APs) from indwelling medical devices used in the neonatal intensive care unit (NICU) may expose premature neonates to these chemicals and their metabolites. The resulting exposure may contribute to medical risks and to impaired (neurocognitive) development of the children after hospital discharge.

This project aims to explore scalp hair and urine as a diagnostic tool for exposure to plasticizers in the extremely vulnerable population of premature neonates. The use of scalp hair to detect past exposure is by itself a novel approach and is expected to provide fresh insights into the role of plasticizers in post NICU morbidity. Within this project, we intend to address the following goals to be pursued:

Objective 1. Exploring the use of a non-invasive matrix (scalp hair) to determine past exposure to plasticizers in neonates. By measuring the levels of DEHP and AP metabolites A/ soon after birth in urine and neonatal scalp hair to determine intra-uterine exposure and B/ during follow-up after NICU discharge in infant scalp hair to determine past exposure in NICU (3 months) and early life (12 months).

Objective 2. To study the extent of leaching of plasticizers from indwelling medical devices used in NICU, by A/ determining the ex vivo leaching from the devices in ambient conditions and taking into account acidity and lipid content with relevance for neonatal care and B/ quantifying levels of plasticizers and metabolites in neonatal urine, collected on daily basis upon NICU admission until discharge.

Objective 3. To study the contribution of exposure to plasticizers leaching from indwelling medical devices used in the NICU, to neurocognitive and pulmonary development during the first year of life.

Importance and impact: NICU saves many lives of premature babies, but the long-term consequences of NICU may jeopardize the quality of life. Hence, finding strategies to prevent or attenuate this legacy is crucial. The completion of this project will lead to a comprehensive characterization of the potential health effects arising from leaching of plasticizers currently used in medical devices in NICU.

The study will be carried out in the NICU of the Antwerp University Hospital (UZA), a 28-beds ICU serving as a tertiary reference centre. We will include neonates with a gestational age under 31 weeks and/or birth weight under 1500 grams. We focus on this group of extreme premature neonates, because of their high and prolonged exposure. Board certified neonatologists will prospectively follow up the neonates. All are exposed to a variable number (range 1-6) of a diversity of indwelling medical devices, leading to a variable degree of exposure in the individual neonate. Term born neonates with age, gender and socio-economic status (not admitted to the NICU, n=100) comparable with those of the patients will be recruited as a control group for non-NICU exposure. The study protocol and informed consent forms have already been approved by the UZA Ethical Committee (Ref. 2003022).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm NICU neonates: Gestational Age < 31 weeks and/or birth weight < 1500 gram
  • Healthy controls: term neonates

Exclusion criteria

  • Major congenital abnormalities

Treatment and study plan

Primary outcomes

  1. Level and sources of NICU exposure to phthalates and alternative plasticizers, measured by liquid chromatography coupled to tandem mass spectrometry in urine samples.

    Time frame: Starting at day 1 postnatal, we collect weekly urine samples, until term age (40 weeks post-menstrual age) or NICU discharge (whatever comes first, up to 120 days postnatally).

    Urine samples are analysed for phthalate and alternative plasticizers' metabolites by liquid chromatography coupled to tandem mass spectrometry at the Antwerp Toxicological Centre. Results will be described as ng/mL.

  2. Level and sources of NICU exposure to phthalates and alternative plasticizers, measured by liquid chromatography coupled to tandem mass spectrometry in hair samples.

    Time frame: Scalp hair samples are being collected at term age (37-40 weeks post menstrual age).

    Hair samples are analysed for phthalate and alternative plasticizers' metabolites by liquid chromatography coupled to tandem mass spectrometry at the Antwerp Toxicological Centre. Results will be described as ng/mg.

  3. Perinatal Morbidity

    Time frame: NICU Discharge (or death, assessed up to 40 weeks post menstrual age)

    Prospective data collection

  4. Perinatal Survival

    Time frame: NICU Discharge (or death, assessed up to 40 weeks post menstrual age)

    Prospective data collection

  5. Respiratory development - 3 months

    Time frame: 3 months corrected for gestational age

    Respiratory questionnaire

  6. Respiratory development - 12 months

    Time frame: 12 months corrected for gestational age

    Respiratory questionnaire

  7. Neurodevelopmental outcome - 3 months

    Time frame: 3 months corrected for gestational age

    Bayley Scales of Infant and Toddler Development (BSID III) - Mean score 100 points, standard deviation 15 points. Higher score corresponds to better outcome

  8. Neurodevelopmental outcome - 12 months

    Time frame: 12 months corrected for gestational age

    Bayley Scales of Infant and Toddler Development (BSID III) - Mean score 100 points, standard deviation 15 points. Higher score corresponds to better outcome

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Research Foundation Flanders
  • Universiteit Antwerpen

Registry information

Official study title

Exposure to Plasticizers in the Neonatal Intensive Care Unit and Long- Term Neurodevelopmental and Pulmonary Toxicity

Acronym: PLASTIC-NICU

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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