Status:
NOT_YET_RECRUITING
Maternal Smoking Exposure and Newborn Outcomes: Study Using Urinary Cotinine
Lead Sponsor:
Haseki Training and Research Hospital
Conditions:
Tobacco Smoke Pollution
Maternal Exposure During Pregnancy
Eligibility:
All Genders
Up to 72 years
Brief Summary
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 obser...
Eligibility Criteria
Inclusion
- 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).
- Maternal urinary cotinine available around delivery (to classify exposure: active, passive, none).
- 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
- Emergent clinical scenarios where any research step could delay urgent care.
- Major congenital anomaly/condition that precludes standard assessments (e.g., cord gas not feasible) per clinician judgment.
- No maternal urine available for cotinine measurement (exposure cannot be defined).
- Prior enrollment of the same neonate (no re-enrollment).
Key Trial Info
Start Date :
October 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT07201181
Start Date
October 13 2025
End Date
March 15 2026
Last Update
October 6 2025
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