Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07427706
Acronym
ETUHeNewBorn
Enrollment
105
Registered
2026-02-23
Start date
2023-02-01
Completion date
2025-09-30
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apgar Score, Cardiopulmonary, Cesarean, Dental, Height, Lactation, Motor Coordination or Function; Developmental Disorder, Smokers, Weight Control

Keywords

newborn, infant, smoking, smoking cessation, primary health care

Brief summary

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.

Interventions

None listed

Sponsors

Institut Investigacio Sanitaria Pere Virgili
Lead SponsorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
CollaboratorOTHER
Institut Catala de Salut
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
head circumference24 monthsThe date and values in cm will be included
Haizea-Llevant Developmental Screening Table - Global Child Development Assessmentfrom birth to 24 monthsThe 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.
Apgar test1 minut, 5 minuts and 10 minutsThe 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.
Mother's pregnancyNumber 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.
weight24 monthsThe date and the values in kilos will be included
height24 monthsThe date and values in cm will be included

Secondary

MeasureTime frameDescription
Another type of screeningFrom enrollment to the end of follow-up, 24 monthsOther 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.
type of deliverytime of deliveryEutocic or dystocic/cesarean
Newborn hearing screeningneonatal 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.
Duration of breastfeedingFrom enrollment to the end of follow-up, 24 monthsNumber 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.
Neonatal early screeningtime of deliveryNormal/anormal

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026