Cord blood test reveals hidden impact of smoking on newborns
NCT ID NCT07201181
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carbon monoxide poisoning are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breast milk from donors vs. formula: which builds a better brain for tiny babies?
- Gentler resuscitation may protect fragile lungs in tiniest babies
- Nasal fentanyl spray could ease painful eye exams for premature babies
- Brain blood flow in tiny patients: study seeks safe surgery limits
- Massive study tracks tiny babies to unlock secrets of early development
- Waiting 30 seconds to clamp the cord could help tiniest babies