PHINE-PRE - Phthalate and Iodine in Preterm Neonates. Screening for plasticizers (phthalates) and iodine in preterm infants and their mothers

PHINE-PRE - Phthalate and Iodine in Preterm Neonates. Screening for plasticizers (phthalates) and iodine in preterm infants and their mothers - PHINE-PRE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039027

Enrollment

Registered

2026-01-22

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3

Interventions

Group 1: The prevalence of phthalate exposure in preterm infants (<34 weeks of gestation) and their mothers is measured at weekly intervals. In addition, urine samples are collected from the preterm i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent of the legal guardians • Legal adulthood of the mother or legal guardian • Preterm birth of the newborn (before completion of the 34th week of gestation) • Inpatient stay in the neonatal intensive care unit

Exclusion criteria

Exclusion criteria: The assessment and decision regarding exclusion due to insufficient suitability lie with the physicians responsible for the neonatal intensive care unit. All cases will be excluded • in which the mother or legal guardians are unable to provide informed consent due to linguistic, psychological, or somatic reasons, • if a palliative situation is assumed. This is the case, for example, when birth occurs before the 22nd week of gestation, the birth weight is below 400 g, or an acute deterioration is anticipated.

Design outcomes

Primary

Measure	Time frame
1) Assessment of the prevalence and concentrations of metabolites of long- and short-chain phthalate esters (MEHP, MEHHP, MEOHP, MECPP, MnHexP, MEP, MnBP, 3OH-MnBP, 2OH-MnBP, MiBP, OH-MiBP, oxo-MiBP, MBzP, MiNP, OH-MiNP, oxo-MiNP, cx-MiNP) in the urine of preterm infants over the course of their stay in the NICU and in their mothers. 2) Prospective assessment of iodine concentrations in the urine of preterm infants and in the urine and breast milk of their mothers to evaluate iodine status.	—

Measure

Time frame

1) Assessment of the prevalence and concentrations of metabolites of long- and short-chain phthalate esters (MEHP, MEHHP, MEOHP, MECPP, MnHexP, MEP, MnBP, 3OH-MnBP, 2OH-MnBP, MiBP, OH-MiBP, oxo-MiBP, MBzP, MiNP, OH-MiNP, oxo-MiNP, cx-MiNP) in the urine of preterm infants over the course of their stay in the NICU and in their mothers. 2) Prospective assessment of iodine concentrations in the urine of preterm infants and in the urine and breast milk of their mothers to evaluate iodine status.

—

Secondary

Measure	Time frame
Clinical data of the preterm infant: • Pre- and postnatal development • Longitudinal laboratory values (complete blood count and serological parameters such as inflammatory markers, thyroid and sex hormones) • Microbiological findings (e.g., blood cultures, swabs) • Longitudinal anthropometric measurements and percentile trajectories • Type of nutrition (breast milk, formula, parenteral nutrition) • Routine examinations (physical examinations, ultrasonography, scheduled pediatric check-ups) • Diagnoses • Therapeutic modalities and complications (medications, surgeries) / interventions (mechanical ventilation, blood transfusions, nasogastric tubes, vascular access, infusions, catheters, incubators and radiant warmers, ECG electrodes, adhesive tapes and wound dressings) • Duration of therapies and length of hospital stay Clinical data of the mother: • Delivery course (mode of delivery, delivery-related complications, medical interventions) • Course of pregnancy (complications and risk factors, use of personal care products, nutrition, supplementation practices) • Postpartum behavioral course (supplementation and breastfeeding practices, nutrition, use of personal care products, skin-to-skin contact with the preterm infant) • Pre-existing conditions and medications	—

Measure

Time frame

Clinical data of the preterm infant: • Pre- and postnatal development • Longitudinal laboratory values (complete blood count and serological parameters such as inflammatory markers, thyroid and sex hormones) • Microbiological findings (e.g., blood cultures, swabs) • Longitudinal anthropometric measurements and percentile trajectories • Type of nutrition (breast milk, formula, parenteral nutrition) • Routine examinations (physical examinations, ultrasonography, scheduled pediatric check-ups) • Diagnoses • Therapeutic modalities and complications (medications, surgeries) / interventions (mechanical ventilation, blood transfusions, nasogastric tubes, vascular access, infusions, catheters, incubators and radiant warmers, ECG electrodes, adhesive tapes and wound dressings) • Duration of therapies and length of hospital stay Clinical data of the mother: • Delivery course (mode of delivery, delivery-related complications, medical interventions) • Course of pregnancy (complications and risk factors, use of personal care products, nutrition, supplementation practices) • Postpartum behavioral course (supplementation and breastfeeding practices, nutrition, use of personal care products, skin-to-skin contact with the preterm infant) • Pre-existing conditions and medications

—

Countries

Germany

Contacts

Public ContactThomas Lücke

Universitätsklinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum

thomas.luecke@klinikum-bochum.de0234/509-2611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026