Assessment of the Effect of Tobacco Consumption on the Health Indicators of Newborns up to 24 Months.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Haizea-Llevant Developmental Screening Table - Global Child Development Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Newborns of participants in the Tobbgest study who provide data (CIP and/or full name) of their offspring.
排除标准
- •- 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.
结局指标
主要结局
Haizea-Llevant Developmental Screening Table - Global Child Development Assessment
时间窗: from birth to 24 months
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.
Apgar test
时间窗: 1 minut, 5 minuts and 10 minuts
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.
Mother's pregnancy
时间窗: Number 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.
weight
时间窗: 24 months
The date and the values in kilos will be included
head circumference
时间窗: 24 months
The date and values in cm will be included
height
时间窗: 24 months
The date and values in cm will be included
次要结局
- 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)
研究者
Cristina Rey Reñones, PhD
Dr, Nurse
Institut Investigacio Sanitaria Pere Virgili