Unidad de Salud Publica y Epidemiologia Nutricional. Departamento de ciencias medicas y basicas
Tarragona, Reus, 43201, Spain
NCT Number: NCT07427706
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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Observational
Tarragona, Reus, 43201, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 24 months
The date and the values in kilos will be included
Time frame: 24 months
The date and values in cm will be included
Time frame: 24 months
The date and values in cm will be included
Time frame: time of delivery
Eutocic or dystocic/cesarean
Time frame: time of delivery
Normal/anormal
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.
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.
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.
Institut Investigacio Sanitaria Pere Virgili
Other
Assessment of the Effect of Tobacco Consumption on the Health Indicators of Newborns up to 24 Months.
Acronym: ETUHeNewBorn
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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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