Clinical Research Directory

Maternal Smoking Exposure and Newborn Outcomes: A Study Using Cord Blood Cotinine

Prenatal exposure to tobacco smoke, whether from active maternal smoking or secondhand exposure, has been associated with adverse neonatal adaptation, metabolic stress, and impaired fetal oxygenation. This single-center prospective observational cohort study will quantify prenatal tobacco exposure using cord blood cotinine measured at delivery and examine its association with early neonatal biochemical, metabolic, and physiologic outcomes. Participants will consist of mother-newborn dyads recruited consecutively at a tertiary academic hospital. After informed consent, cord blood obtained at delivery will be used for cotinine measurement. Based on pre-specified cotinine thresholds and maternal smoking history, newborns will be classified into three exposure groups: active exposure, passive exposure, or no exposure. No experimental intervention will be administered, and neonatal assessments will be based on routine perinatal and postnatal care. Neonatal data collected will include umbilical cord blood gas parameters (pH, pCO2, pO2, base excess, bicarbonate, and lactate), fetal carboxyhemoglobin (FCOHb), birthweight and anthropometric measurements, Apgar scores, oxygen saturation, heart rate, blood pressure, and routine laboratory indices obtained during the first postnatal day. These laboratory measures may include complete blood count parameters, inflammatory and hematologic ratios such as NLR and PLR, metabolic markers including albumin and lactate-to-albumin ratio, lipid parameters such as HDL and LDL, thyroid-stimulating hormone from the standard newborn screening program, and hearing screening results. Early follow-up data, including postnatal weight loss and bilirubin measurements at routine visits, will also be recorded where available. Maternal and perinatal covariates, including maternal age, parity, gestational age, delivery mode, intrapartum factors, smoking history, and relevant maternal comorbidities, will be collected to support adjusted analyses. The primary objective is to determine whether higher cord blood cotinine-defined exposure is associated with greater metabolic stress and impaired fetal oxygenation at birth, particularly as reflected by cord lactate, related blood gas parameters, and FCOHb. Secondary objectives include evaluating associations with early neonatal hematologic, metabolic, endocrine, and clinical indices, including birthweight, blood pressure, bilirubin levels, thyroid screening results, and hearing screening outcomes. The study will recruit consecutive eligible dyads in a prospective manner. Statistical analyses will follow a pre-specified plan and will include multivariable regression models to adjust for potential confounding factors. Sensitivity and subgroup analyses, including analyses by delivery mode and other clinically relevant strata, will be performed when feasible. This study is designed to provide prospectively collected, biochemically verified evidence on how prenatal tobacco exposure, classified by cord blood cotinine, relates to immediate neonatal metabolic, hematologic, and physiologic outcomes using measurements that are feasible within routine clinical 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.