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Study Title and Description

Maternal caffeine consumption and infant nighttime waking: prospective cohort study.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title Maternal caffeine consumption and infant nighttime waking: prospective cohort study.
Author IS Santos,A Matijasevich,MR Domingues,
Country
Year 2012
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 22473365
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? This study was planned to assess prevalence of heavy caffeine consumption by pregnant and nursing women, to describe nocturnal sleep pattern at 3 monthsof age,andto investigatewhether maternal caffeine consumption during pregnancy and lactation would lead tomore frequent nocturnal awakening episodes among infants at 3 months of age.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) All children born in the city of Pelotas, Brazil, during 2004 were enrolled on a cohort study. Mothers were interviewed at delivery and after 3 months to obtain information on caffeine drinking consumption (Caffeine sources analyzed were coffee (instant and ground) and mate, sociodemographic, reproductive, and behavioral characteristics. Infant sleeping pattern in the previous 15 days was obtained from a subsample. The subsample included 885 of the 4231 infants born in 2004. Caffeine variables in milligrams were generated considering the source, preparing method, frequency, and amount consumed per serving to establish the average daily amount of caffeine per trimester, as used previously in another study21: samples of filtered coffee (without adding sugar or milk) and the used leaves of mate drink were collected at households and assessed for caffeine content by liquid chromatography. From these analyses, it was possible to infer the following average milligram of caffeine per milliliter: strong coffee, 0.25 mg/mL (45 mg per cup of 180 mL); medium strength coffee, 0.20 mg/mL (36 mg per cup); and weak coffee, 0.11 mg/mL (19.8 mg per cup). For mate drink, the analyses revealed an average concentration of 17 mg of caffeine per 100 mL of liquid (∼10 mg per gourd). Infants frommothers consuming $300 mg/day of caffeine (heavy consumers) were considered exposed. Night waking was defined as an episode of infant arousal that woke the parents during nighttime. Infants usually waking up more than 3 times a night were considered as presenting frequent night waking. Multivariable analysis was performed by using Poisson regression.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Infant night time waking
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes Night waking was defined as an episode of infant arousal that woke the parents during nighttime. Infants usually waking up more than 3 times a night were considered as presenting frequent night waking.
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Clinical
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Physiological Physiological
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Other Other
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What is the study design? Cohort
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Both
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Optional: Name of Method or short description Self-reported
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Caffeine mg/day: <300, >/=300
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) Other exposures investigated were maternal age in complete years; skin color; schooling; parity; smoking (at least 1 cigarette per day everyday in at least 1 trimester of pregnancy);amount smoked per day; living with or without a partner; alcohol consumption during pregnancy; paid work; family monthly income; and maternal depression.
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Provide a general description of results (as reported by the authors). The highest prevalence ratio was observed among breastfed infants from mothers consuming >/=300 mg/ day during the whole pregnancy and during the postpartum period (1.65; 95% CI: 0.86–3.17) but at a nonsignificant level. Looking at caffeine consumption as a continuous variable in milligrams per day or employing international parameters to estimate caffeine consumption from filtered coffee did not change these results. We assessed the effect of caffeine on child’s crying (a symptom of infant activity) and colic at 3 months of age for the entire cohort (n = 3985), as well as for frequent night waking at 12 months (n = 3907) and found no association in crude or adjusted analyses (data available upon request).
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Did the authors perform a dose-response analysis (or trend/related analysis)? Yes
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What were the authors's observations re: trend analysis? "Looking at caffeine consumption as a continuous variable in milligrams per day...did not change these results
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What were the author's conclusions? In this setting where coffee and mate are largely consumed by women during and after pregnancy, heavy consumption did not increase the number of nighttime awakenings by their 3-month-old infants. These findings confirm the fact that the advised limit of caffeine consumption during pregnancy at a level of 300mg/day as recommended in some countries can be kept, at least as the sleeping behavior of infants is concerned.
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What were the sources of funding? This article is based on data from the study "Pelotas birth cohort, 2004" conducted by the Postgraduate Program in Epidemiology at Universidade Federal de Pelotas. The 2004 birth cohort study is currently supported by the Wellcome Trust Initiative entitled Major Awards for Latin America on Health Consequences of Population Change. Previous phases of the study were supported by the World Health Organization, National Support Program for Centers of Excellence, the Brazilian National Research Council, the Brazilian Ministry of Health, and the Children’s Mission.
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What conflicts of interest were reported? The authors have indicated they have no financial relationships relevant to this article to disclose.
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Infant night time waking NOAEL = >/=300 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. <300 vs. >/=300
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What is the importance of the study with respect to the adverseness of the outcome? Low
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