Not Yet RecruitingNot Applicable

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

126 participantsStarted 2026-05-04

Plain-language summary

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.

Who can participate

Age range

0 Minutes – 72 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Liveborn neonate delivered at the study hospital, aged 0-72 hours at assessment. * Routine umbilical cord blood gas available at birth (pH, base excess, lactate). * Cord blood cotinine available or obtainable at delivery for exposure classification. * Singleton live birth at ≥35 weeks of gestation. * Availability of routine umbilical cord blood gas parameters at birth, including at minimum pH, base excess, and lactate, with FCOHb recorded where available. * Availability of routine first postnatal day clinical and laboratory data according to unit practice. * Parent/guardian provides informed consent for use of neonatal data obtained from routine care. * Standard newborn assessments obtainable within 72 hours (e.g., birthweight, \~6-hour vitals/BP, TSH at 24-48 h, hearing screen ≤72 h per unit practice). Exclusion Criteria: * Emergent clinical scenarios where any research step could delay urgent care. * Major congenital anomaly, known chromosomal/genetic disorder, or major metabolic disease likely to affect neonatal adaptation or study outcomes. * Severe perinatal condition preventing acquisition of core study data or making outcome interpretation unreliable, including major birth trauma or prolonged intensive care requirement. * Missing cord blood cotinine measurement or missing core primary outcome data. * Multiple gestation. * Prior enrollment of the same neonate (no re-enrollment).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Umbilical Cord Blood Lactate

Timeframe: At birth (sample obtained within 10 minutes of delivery; analyzed within routine lab turnaround)

Trial details

NCT IDNCT07201181

SponsorHaseki Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-04

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