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Completed

NCT Number: NCT07427706

Effect of Tobacco Use on the Health of the Newborn up to 24 Months.

There is scientific evidence suggesting that tobacco use during pregnancy is associated with several adverse effects in newborns, including low birth weight, respiratory complications, severe neonatal morbidity, perinatal death, and a higher risk of infections and neurological problems.

Newborns of mothers who smoked during pregnancy show worse health indicators at birth and during the first years of life compared to those whose mothers quit smoking before pregnancy. The aim is to determine whether there are differences in the main health indicators between newborns whose mothers stopped smoking during pregnancy and those who were exposed to their mothers' tobacco use.

This is a retrospective descriptive study of the Tobbgest study cohort, and the study will be conducted within the Primary and Community Health care setting.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidad de Salud Publica y Epidemiologia Nutricional. Departamento de ciencias medicas y basicas

Tarragona, Reus, 43201, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns of participants in the Tobbgest study who provide data (CIP and/or full name) of their offspring.

Exclusion criteria

  • Newborns who do not follow the healthy child preventive activities program or whose data is not recorded in the Primary Care Clinical Station (ECAP), the primary care computer program in Catalonia.

Treatment and study plan

Primary outcomes

  1. Haizea-Llevant Developmental Screening Table - Global Child Development Assessment

    Time frame: from birth to 24 months

    The Haizea-Llevant Developmental Table is a pediatric screening tool used to assess psychomotor development in children from birth to 5 years of age. A trained health professional conducts direct observation of the child and asks standardized questions to caregivers to verify the acquisition of developmental milestones. The instrument is organized by age in months and evaluates four domains: socialization, language and communication, fine motor manipulation, and gross motor/postural skills. Each item indicates the age range at which most children achieve the skill. If a child does not complete an expected task, earlier milestones in the same domain are assessed to determine functional level. Results are classified as normal, monitoring/risk, or suspected developmental delay, guiding follow-up or referral. It is a screening, not diagnostic, measure.

  2. Apgar test

    Time frame: 1 minut, 5 minuts and 10 minuts

    The Apgar test is the first vital examination performed on a newborn in the first minutes of life. This test has proven to be very important in quickly detecting diseases or complications in the newborn and has even significantly reduced their mortality rate.

    Therefore, the Apgar test helps to understand the baby's condition at the time of birth. The normal Apgar score ranges are around 7-10. For example, if the Apgar score is 9/10, it means there was a change in the score between the first measurement at one minute of life and the next measurement at five minutes.

  3. Mother's pregnancy

    Time frame: Number of weeks of pregnancy. The value is usually between 20 and 42 weeks.

    Weeks of gestation of the mother. From the date of the last menstrual period until the day of delivery.

  4. weight

    Time frame: 24 months

    The date and the values in kilos will be included

  5. height

    Time frame: 24 months

    The date and values in cm will be included

  6. head circumference

    Time frame: 24 months

    The date and values in cm will be included

Secondary outcomes

  1. type of delivery

    Time frame: time of delivery

    Eutocic or dystocic/cesarean

  2. Neonatal early screening

    Time frame: time of delivery

    Normal/anormal

  3. Newborn hearing screening

    Time frame: neonatal period, usually before discharge from the maternity center,

    Newborn hearing screening is an early detection procedure aimed at identifying infants with suspected hearing loss ≥40 dB to allow prompt diagnosis, treatment, and follow-up. The test is performed in the neonatal period, usually before discharge from the maternity center, by trained healthcare professionals using objective, non-invasive methods (otoacoustic emissions and/or automated auditory brainstem response) while the infant is calm or asleep. Outcomes are classified as pass or refer (altered). If the first test is altered, a repeat screening appointment is scheduled after discharge. If the second result remains altered, the infant is referred urgently to a specialized Hearing Loss Reference Unit for complete audiological evaluation and initiation of appropriate management.

  4. Duration of breastfeeding

    Time frame: From enrollment to the end of follow-up, 24 months

    Number of weeks in which the newborn has been fed through breastfeeding. It will be recorded whether it has been exclusive breastfeeding, mixed feeding (a combination of breastfeeding and formula feeding), or formula feeding. The introduction of complementary foods (fruit, vegetables, meat, egg, fish, cereals, others) will also be recorded.

  5. Another type of screening

    Time frame: From enrollment to the end of follow-up, 24 months

    Other aspects of the newborn will be observed, such as the skin, head, cardiopulmonary system, abdomen, inguinal area, genitourinary system, musculoskeletal system, ENT, ophthalmology, and oral health. It will be recorded whether they are normal or if any abnormalities are present. In case of an abnormality, it will be described in detail.

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Institut Catala de Salut

Registry information

Official study title

Assessment of the Effect of Tobacco Consumption on the Health Indicators of Newborns up to 24 Months.

Acronym: ETUHeNewBorn

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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