The Safe Passage Study: Design, Methods, Recruitment, and Follow-Up Approach

被引：95

作者：

Dukes, Kimberly A. ^{[1
]}

Burd, Larry ^{[6
]}

Elliott, Amy J. ^{[7
]}

Fifer, William P. ^{[8
,9
,10
]}

Folkerth, Rebecca D. ^{[2
,3
,4
]}

Hankins, Gary D. V. ^{[11
]}

Hereld, Dale ^{[12
]}

Hoffman, Howard J. ^{[13
]}

Myers, Michael M. ^{[8
,9
,10
]}

Odendaal, Hein J. ^{[15
]}

Signore, Caroline ^{[14
]}

Sullivan, Lisa M. ^{[5
]}

Willinger, Marian ^{[14
]}

Wright, Colleen ^{[16
,17
]}

Kinney, Hannah C. ^{[3
,4
]}

机构：

[1] DM STAT Inc, Malden, MA 02148 USA

[2] Brigham & Womens Hosp, Dept Pathol, Boston, MA 02115 USA

[3] Boston Childrens Hosp, Dept Pathol, Boston, MA USA

[4] Harvard Univ, Sch Med, Boston, MA USA

[5] Boston Univ, Sch Publ Hlth, Dept Biostat, Boston, MA USA

[6] Univ N Dakota, Sch Med, Grand Forks, ND 58202 USA

[7] Sanford Res, Ctr Hlth Outcomes & Prevent, Sioux Falls, SD USA

[8] Columbia Univ, Dept Psychiat, New York, NY USA

[9] Columbia Univ, Dept Pediat, New York, NY 10027 USA

[10] New York State Psychiat Inst & Hosp, New York, NY 10032 USA

[11] Univ Texas Med Branch, Galveston, TX 77555 USA

[12] NIAAA, Rockville, MD 20852 USA

[13] NIDCD, Epidemiol & Stat Program, Div Sci Programs, Bethesda, MD USA

[14] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Bethesda, MD USA

[15] Univ Stellenbosch, Dept Obstet & Gynecol, ZA-7600 Stellenbosch, Western Cape, South Africa

[16] Univ Stellenbosch, Fac Med & Hlth Sci, Dept Pathol, ZA-7600 Stellenbosch, Western Cape, South Africa

[17] Natl Hlth Lab Serv, Port Elizabeth, Eastern Cape, South Africa

来源：

PAEDIATRIC AND PERINATAL EPIDEMIOLOGY | 2014年 / 28卷 / 05期

关键词：

PASS; Safe Passage Study; fetal alcohol spectrum disorders; prenatal alcohol exposure; stillbirth; sudden infant death syndrome; study methodology; FETAL ALCOHOL SYNDROME; INFANT-DEATH-SYNDROME; SPECTRUM DISORDERS; NORTHERN PLAINS; YOUNG-ADULTS; DRINKING; STILLBIRTH; PREGNANCY; RISK; MORTALITY;

D O I：

10.1111/ppe.12136

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

BackgroundThe Safe Passage Study is a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders. MethodsThe results provided are based on an interim assessment of 6004 women enrolled, out of the 12000 projected, from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research objectives, study design, and descriptive statistics, including consent, recruitment, and retention information, are provided. ResultsOverall visit compliance is 87%, and includes prenatal, delivery/newborn, and postnatal contacts through 1 year post-delivery. Pregnancy outcome ascertainment is 98% prior to medical chart review; less than 2% of women withdraw. Consent for the use of DNA and placental tissue exceed 94%, and consent to participate in the autopsy portion of the study is 71%. ConclusionsThe Safe Passage Study is the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success are close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures.

引用

页码：455 / 465

页数：11

共 38 条

[1]

1996 International Conference on Harmonisation E-6(R1), 1996, 1996 INT C HARM E 6

[2] Update of the Amiel-Tison neurologic assessment for the term neonate or at 40 weeks corrected age [J].