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Study Title and Description

Descriptive and risk factor analysis for choanal atresia: The National Birth Defects Prevention Study, 1997-2007.



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 Descriptive and risk factor analysis for choanal atresia: The National Birth Defects Prevention Study, 1997-2007.
Author V Kancherla,PA Romitti,L Sun,JC Carey,TL Burns,AM Siega-Riz,CM Druschel,AE Lin,RS Olney, ,
Country
Year 2014
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 24576610
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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)? The hypothesized role of neural crest cell migration in the development of choanal atresia and the potential for this migration to be disrupted by environmental exposures during pregnancy suggest the need for a comprehensive, population-based etiological investigation of this defect. As such, an analysis of data from a multisite, population-based case-control study, the National Birth Defects Prevention Study (NBDPS), was conducted. This analysis of NBDPS data permitted examination of the independent associations between several selected exposures and choanal atresia, while adjusting for relevant covariables.
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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) Data from the National Birth Defects Prevention Study, a population-based case-control study, were used to examine associations between maternal self-reports of exposures and occurrence of choanal atresia in their offspring. Overall, 117 case and 8350 control mothers with deliveries from 1997 through 2007 provided telephone interview reports of pre-pregnancy (one year before conception) and periconceptional (one month before through three months after conception) exposures. Choanal atresia was defined as a congenital obstruction of the posterior choana(e) and coded using the modified British Paediatric Association (BPA) codes implemented by the CDC. Clinical geneticists at each NBDPS site confirmed the diagnosis of choanal atresia by review of data abstracted from medical records. All identified choanal atresia cases were reviewed by a second clinical geneticist (J.C.C.) and included as choanal atresia if documented on CT scan or by examination at time of treatment (surgery or laser) or at postmortem. Choanal atresia cases that were part of a known genetic syndrome or complex were excluded from the NBDPS. Systematic data-collection protocol was used to consent and administer a telephone interview to case and control mothers. The interviews were conducted no earlier than 6weeks and no later than 24 months after the EDD. The exposures analyzed were pre-pregnancy dietary intake, prepregnancy and periconceptional caffeine consumption, and periconceptional cigarette smoking, alcohol drinking, and medication use. Maternal pre-pregnancy caffeine exposure was estimated using the responses in the Willet food frequency questionnaire to chocolate consumption and in the NBDPS beverage module for consumption of caffeinated beverages (coffee, tea, and soda) as calculated in previous NBDPS analyses. Independent associations between each exposure and all choanal atresia cases combined (n = 117) and isolated choanal atresia cases (those without additional unrelated major defects; n = 61) were examined. Odds ratios (ORs), both unadjusted (uORs) and adjusted (aORs) for potential confounders, and 95% confidence intervals (CIs) were estimated using unconditional logistic regression analysis.
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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) Choanal atresia
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes defined as a congenital obstruction of the posterior choana(e) and coded using the modified British Paediatric Association (BPA) codes implemented by the CDC
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Clinical Clinical
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Physiological
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Other
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What is the study design? Case-Control
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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 Defined as a congenital obstruction of the posterior choana(e) and coded using the modified British Paediatric Association (BPA) codes implemented by the CDC. Clinical geneticists at each NBDPS site confirmed the diagnosis of choanal atresia by review of data abstracted from medical records. All identified choanal atresia cases were reviewed by a second clinical geneticist (J.C.C.) and included as choanal atresia if documented on CT scan or by examination at time of treatment (surgery or laser) or at postmortem
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea 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: <100, 100<200, 200-<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) Selected case and control characteristics (sex, birth weight, gestational age at delivery, plurality, and family history of choanal atresia), maternal characteristics (age at delivery, race/ethnicity, education, pre-pregnancy body mass index [BMI], parity, nativity, folic acid use, type 1 or 2 diabetes before index pregnancy, history of hypertension, season of conception, and periconceptional exposure to cigarette smoking and alcohol) and study site were compared between case and control mothers. Selected medication classes, identified from previous findings for choanal atresia (thyroid and anti-thyroid medications) or orofacial clefts (anti-epileptics, acne medications [isotretinoin], retinoids, corticosteroids, and non-steroidal antiinflammatory agents) and not previously examined for choanal atresia using NBDPS data, were chosen for analysis.
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Provide a general description of results (as reported by the authors). Maternal pre-pregnancy reports of different amounts of caffeinated coffee, tea, and soda consumption compared to no reported pre-pregnancy consumption produced aORs near or below unity for all choanal atresia cases combined. Conversely, for isolated cases, a dose-response effect (CochraneArmitage trend test pvalue< 0.05) was found for reports of pre-pregnancy coffee consumption of 1-2 cups per day (aOR=. 1.7; 95% CI = 1.0, 3.1) and of 3 or more cups per day (aOR = 2.5; 95% CI = 1.1, 5.6) compared to less than 1 cup per day. The aORs for reported caffeinated tea or soda consumption were near or below unity for isolated cases. Cumulative exposure to caffeine from all sources queried (coffee, tea, soda, and chocolate) tended to show weakly positive or negative aORs for all cases combined and positive, but nonsignificant, aORs for isolated cases. Analyses were rerun following exclusion of mothers who reported a change in intake. This exclusion did not materially change the aORs observed (data not shown); thus, aORs for all mothers are presented.
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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? No trend for total caffeine, tea, or soda. For coffee a dose-response effect (CochraneArmitage trend test pvalue< 0.05) was found.
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What were the author's conclusions? In summary, findings from the current study suggest that choanal atresia may be associated with sub-optimal pre-pregnancy exposure to selected nutrients and increasing daily exposure to coffee and periconceptional active cigarette smoking and selected medication use. Because of the large number of associations tested, these findings may be due to chance; however, they contribute new hypotheses regarding the etiology of choanal atresia which deserve investigation in additional population-based studies.
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What were the sources of funding? This work was funded by grants (5U01DD000492 and 1U01DD001035) from the Centers for Disease Control and Prevention (CDC). The CDC was a participating site in the NBDPS and contributed to: study design; data collection, analysis, and interpretation; co-authoring the article, and in the decision to submit the article for publication. Coding of drug information in the National Birth Defects Prevention Study used the Slone Drug Dictionary under license from the Slone Epidemiology Center of Boston University. Nutritional analysis was supported by grant no. DK56350 from the Nutrition Epidemiology Core of the University of North Carolina Clinical Nutrition Research Center. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
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What conflicts of interest were reported? None reported
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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.  Choanal atresia: NOAEL = >/=300 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. >/=300 mg/day aOR = 4.4 (0.5-3.6)
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What is the importance of the study with respect to the adverseness of the outcome? Important
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Baseline Characteristics
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Results & Comparisons

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Adverse Events
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Quality Dimensions
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