Clinical Research Directory

Maternal Smoking Exposure and Newborn Outcomes: Study Using Urinary Cotinine

Prenatal exposure to tobacco smoke-whether from active maternal smoking or secondhand exposure-has been linked to adverse neonatal adaptation and metabolic stress. This single-center prospective observational cohort will quantify maternal smoking exposure using maternal urinary cotinine around delivery and examine its association with early neonatal physiologic and biochemical outcomes within the first 24 hours of life. Participants will be pregnant individuals delivering at a tertiary academic hospital and their newborns. After consent, mothers will provide a urine sample for cotinine measurement. Based on pre-specified cotinine thresholds and maternal history, dyads will be classified into three exposure groups: Active smoker, Passive exposure, or No exposure. No experimental intervention is administered; all neonatal assessments are part of routine peripartum care. Neonatal data collected (per standard practice) will include: umbilical cord blood gas parameters (pH, base excess, lactate) and fetal carboxyhemoglobin (FCOHb); birthweight; vital signs/blood pressure at \~6 hours; routine laboratory indices (e.g., hemogram, lipids such as HDL/LDL where available per unit protocol); heel-prick TSH from the standard newborn screen; and hearing screening result prior to discharge. Additional maternal and perinatal covariates (e.g., age, parity, gestational age, delivery mode, intrapartum events) will be recorded to support adjusted analyses. No extra phlebotomy beyond standard care will be performed; the study leverages existing clinical samples and measurements. Primary objective is to determine whether higher maternal cotinine-defined exposure is associated with greater metabolic stress at birth (indexed by cord lactate and related gas parameters) and higher FCOHb. Key secondary objectives include evaluating associations with birthweight, early blood pressure, TSH, hearing screen outcomes, and routine laboratory markers. Prespecified subgroup and sensitivity analyses (e.g., by gestational age strata or delivery mode) will be conducted as feasible. The planned sample includes approximately three cotinine-stratified cohorts recruited consecutively. Statistical analyses will follow a pre-registered plan using multivariable regression to adjust for confounders; ROC analyses may be used to explore cotinine thresholds predictive of adverse neonatal indices. Enrollment is anticipated to start October 13, 2025, with primary data collection completed within 2-3 months of recruitment initiation. This study will provide pragmatic, prospectively collected evidence on how biochemically verified maternal tobacco exposure relates to immediate neonatal metabolic, cardiovascular, endocrine, and auditory outcomes, using measurements obtainable in routine care.

GenerationGemelli: Longitudinal Study for the Evaluation of the Maternal Exposome on the Health of the Newborn and Child

The study involves the establishment of a case-control study within a birth cohort. With approximately 4,000 annual deliveries, the aim is to enroll 140 cases (newborns with intrauterine growth restriction \[IUGR\] and premature birth) and 280 controls each year, starting from September 2022. A comprehensive questionnaire will be utilized to gather information about various types of maternal environmental exposures before and during pregnancy. Biological samples will be collected from both mothers and newborns (including vaginal swab, placenta sample, blood, saliva, meconium, and bronchoalveolar lavage fluid) at birth and within the early hours of the newborn's life. Laboratory examinations will include the measurement of heavy metals and essential elements, investigation of placental distress and fetal brain damage biomarkers, analysis of microbiota, and assessment of DNA methylation profiles. Clinical follow-up assessments will be conducted in both cases and controls at 12 and 24 months, during which anthropometric data, types of feeding with particular reference to breastfeeding and its duration, pediatric emergency room visits, hospitalizations, medication usage, known allergies, and neuropsychological development will be collected.