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Cord blood test reveals hidden impact of smoking on newborns

NCT ID NCT07201181

Knowledge-focused Sponsor: Haseki Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study looks at how tobacco smoke exposure before birth—whether from active smoking or secondhand smoke—affects a newborn's health right after delivery. Researchers will measure a chemical called cotinine in the baby's cord blood to classify exposure as active, passive, or none. They will then compare health markers like blood gases, oxygen levels, and birth weight among the groups. No treatments are given; the goal is simply to gather information to better understand the risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how tobacco smoke affects newborns, leading to improved prenatal care advice.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a single-center prospective cohort study conducted at a tertiary hospital. Consecutive eligible mother-newborn dyads are recruited during the delivery hospitalization. Maternal clean-catch urine is collected within 24 hours before delivery for cotinine and creatinine measurement. Dyads are classified as active exposure, passive exposure, or no exposure according to prespecified urinary cotinine-to-creatinine thresholds and maternal exposure history. Outcomes are obtained mainly from routine care and include cord blood lactate, pH, base excess, FCOHb, birthweight, anthropometric measurements, Apgar scores, vital signs, early laboratory results, newborn screening TSH, hearing screening, and follow-up weight loss and bilirubin where available. No experimental intervention or additional neonatal blood sampling is planned.

Ages

0 minutes to 72 hours

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant individual expected to deliver a liveborn infant at the study hospital and providing written informed consent before delivery. * Singleton pregnancy with an anticipated gestational age of ≥35 completed weeks at delivery. * Maternal clean-catch urine sample obtainable within 24 hours before delivery, preferably at admission and before intravenous fluid administration, for urinary cotinine and creatinine measurement. * Availability of routine umbilical cord blood gas analysis at birth, including at minimum lactate, pH, and base excess, with fetal carboxyhemoglobin recorded when available. * Availability of routine neonatal clinical data, including birthweight, anthropometric measurements, Apgar scores, vital signs, and early postnatal assessments according to unit practice. Exclusion Criteria: * Multiple gestation. * Major congenital anomaly, known chromosomal or genetic disorder, or major metabolic disease likely to affect neonatal adaptation or the study outcomes. * Emergency clinical circumstances in which obtaining informed consent or the maternal urine sample could delay or interfere with urgent maternal or neonatal care. * Inability to obtain an adequate maternal urine sample before delivery for cotinine and creatinine measurement. * Severe perinatal condition preventing acquisition or reliable interpretation of the primary outcome data, including major birth trauma or prolonged intensive care requirement. * Missing umbilical cord blood lactate measurement or other critical primary outcome data. * Previous enrollment of the same mother-newborn dyad.

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Conditions

The condition(s) this trial relates to.

carbon monoxide poisoning

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carbon monoxide poisoning Infant, newborn Maternal exposure during pregnancy Tobacco smoke pollution

How to take part

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  1. The official record

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Other studies related to the condition(s) this trial covers.