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Apgar ScoreETUHeNewBornNCT07427706

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

An observational study of Apgar Score and Motor Coordination or Function; Developmental Disorder, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
105 participants
Where
1 siteSpain
Study dates
1 Feb 2023to 30 Sep 2025
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Newborns of pregnant women who are smokers or former smokers

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Tarragona, Reus, 43201

Other trials in Spain

About this study

Official title: 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.

Keywords
newborn, infant, smoking, smoking cessation, primary health care
Medical subject headings
Developmental Disabilities, Breast Feeding, Smoking, Smoking Cessation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from birth to 24 months

  2. 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.

    Measured: 1 minut, 5 minuts and 10 minuts

  3. Mother's pregnancy

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

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

  4. weight

    The date and the values in kilos will be included

    Measured: 24 months

  5. height

    The date and values in cm will be included

    Measured: 24 months

  6. head circumference

    The date and values in cm will be included

    Measured: 24 months

Secondary outcomes (5)

  1. type of delivery

    Eutocic or dystocic/cesarean

    Measured: time of delivery

  2. Neonatal early screening

    Normal/anormal

    Measured: time of delivery

  3. 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.

    Measured: neonatal period, usually before discharge from the maternity center,

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start1 Feb 2023
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
105 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07427706
Sponsor's protocol ID
25/050-P
Acronym
ETUHeNewBorn
Status last verified
Feb 2026
First submitted
9 Feb 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Apgar Score and Motor Coordination or Function; Developmental Disorder, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Haizea-Llevant Developmental Screening Table - Global Child Development Assessment (time frame: from birth to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07427706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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