CompletedNot Applicable

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

Spain105 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Haizea-Llevant Developmental Screening Table - Global Child Development Assessment

Timeframe: from birth to 24 months

Apgar test

Timeframe: 1 minut, 5 minuts and 10 minuts

Mother's pregnancy

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

weight

Timeframe: 24 months

height

Timeframe: 24 months

head circumference

Timeframe: 24 months

Trial details

NCT IDNCT07427706

SponsorInstitut Investigacio Sanitaria Pere Virgili

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Apgar Score trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Haizea-Llevant Developmental Screening Table - Global Child Development Assessment

Timeframe: from birth to 24 months

Apgar test

Timeframe: 1 minut, 5 minuts and 10 minuts

Mother's pregnancy

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

weight

Timeframe: 24 months

height

Timeframe: 24 months

head circumference

Timeframe: 24 months