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

Assessment of the Effect of Tobacco Consumption on the Health Indicators of Newborns 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.

Study Overview

• Status: Completed
• Conditions: Cesarean; Lactation; Apgar Score; Smokers; Height; Motor Coordination or Function; Developmental Disorder; Weight Control; Cardiopulmonary; Dental

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Spain
  • Reus
    • Tarragona, Reus, Spain, 43201
      • Unidad de Salud Publica y Epidemiologia Nutricional. Departamento de ciencias medicas y basicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newborns of pregnant women who are smokers or former smokers

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haizea-Llevant Developmental Screening Table - Global Child Development Assessment	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.	from birth to 24 months
Apgar test	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.	1 minut, 5 minuts and 10 minuts
Mother's pregnancy	Weeks of gestation of the mother. From the date of the last menstrual period until the day of delivery.	Number of weeks of pregnancy. The value is usually between 20 and 42 weeks.
weight	The date and the values in kilos will be included	24 months
height	The date and values in cm will be included	24 months
head circumference	The date and values in cm will be included	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of delivery	Eutocic or dystocic/cesarean	time of delivery
Neonatal early screening	Normal/anormal	time of delivery
Newborn hearing screening	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.	neonatal period, usually before discharge from the maternity center,
Duration of breastfeeding	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.	From enrollment to the end of follow-up, 24 months
Another type of screening	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.	From enrollment to the end of follow-up, 24 months

Collaborators and Investigators

• Sponsor: Institut Investigacio Sanitaria Pere Virgili
• Collaborators: Institut Catala de Salut; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Publications and helpful links

General Publications

• 1. Margarita D, Malpartida K, Médico C, Rica C. Factores para un embarazo de riesgo. Rev Médica Sinerg. 2019;4(9). 2. Drope F, Schluger NW. The Tobacco Atlas. Sixth Ediction [Internet]. Jeffrey Drope P, Neil W. Schluger M, editors. American Cancer Society, Inc.; 2018. Disponible en: https://tobaccoatlas.org/topic/prevalence/ 3. Räisänen S, Kramer MR, Gissler M, Saari J, Hakulinen--Viitanen T, Heinonen S. Smoking during pregnancy was up to 70% more common in the most deprived municipalities. A multilevel analysis of all singleton births during 2005-2010 in Finland. Prev Med (Baltim). 2014;67:6 -11. 4. Scherman A, Tolosa JE, McEvoy C. Smoking cessation in pregnancy: a continuing challenge in the United States. Ther Adv Vaccines. 2018;9(8):457 -74. 5. Ministerio de Sanidad SS e I. Encuesta Domiciliaria sobre consumo de Alcohol y Drogas en España (EDADES) 2013-2014. Madrid; 2015. 6. Mateos-Vílchez PM, Aranda-Regules JM, Díaz-Alonso G, Mesa-Cruz P, Gil-Barcenilla B, Ramos-Monserrat M, et al. Smoking Prevalence and Associated Factors During Pregnancy in Andalucía. Rev Esp Salud Pública.2014;88:369-81. 7. Agència de Salut Pública. Indicadors de salut perinatal a Catalunya. Any 2018. Informe executiu Generalitat de Catalunya. 2020;1-11. 8. Generalitat de Catalunya. Protocol de seguiment d el'embaràs a Catalunya. 3a Edició. Barcelona; 2018. 9. De Queiroz Andrade E, Da Silva Sena C, Collison A, Murphy V, Gould G, Bonevski B, et al. Association between active tobacco use during pregnancy and infant respiratory health: a systematic review and meta-analysis. BMJ Open. 2020. 10. https://doi.org/10.1136/bmjopen-2020-037819. 10. Hamadneh S, Hamadneh J. Active and Passive Maternal Smoking During Pregnancy and Birth Outcomes: A Study From a Developing Country. Ann Glob Health. 2021;87(1):122. https://doi.org/10.5334/aogh.3384 11. Agràs-Guàrdia M, Martínez-Torres S, Granado-Font E, Pallejà-Millán M, Villalobos F, Patricio D, et al. Effectiveness of an App for tob

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; infant; primary health care; newborn
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Behavior; Health Behavior; Feeding Behavior; Developmental Disabilities; Smoking; Smoking Cessation; Breast Feeding
• Other Study ID Numbers: 25/050-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No