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

NCT07427706 | Completed

• 1 other identifier: 25/050-P
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

newborn; infant; smoking; smoking cessation; primary health care

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• type of delivery

  time of delivery

• Neonatal early screening

  time of delivery

• Newborn hearing screening

  neonatal period, usually before discharge from the maternity center,

• Duration of breastfeeding

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

• Another type of screening

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newborns of pregnant women who are smokers or former smokers

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Tarragona, Reus, 43201, Spain

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Developmental Disabilities; Breast Feeding; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Feeding Behavior; Behavior; Health Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Nurse

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)