BACKGROUND: The 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. METHODS: The results provided are based on an interim assessment of 6004 women enrolled, out of the 12,000 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. RESULTS: Overall 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%. CONCLUSIONS: The 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.
BACKGROUND: The 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. METHODS: The results provided are based on an interim assessment of 6004 women enrolled, out of the 12,000 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. RESULTS: Overall 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%. CONCLUSIONS: The 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.
Authors: Solomon Iyasu; Leslie L Randall; Thomas K Welty; Jason Hsia; Hannah C Kinney; Frederick Mandell; Mary McClain; Brad Randall; Don Habbe; Harry Wilson; Marian Willinger Journal: JAMA Date: 2002-12-04 Impact factor: 56.272
Authors: Henry F Krous; J Bruce Beckwith; Roger W Byard; Torleiv O Rognum; Thomas Bajanowski; Tracey Corey; Ernest Cutz; Randy Hanzlick; Thomas G Keens; Edwin A Mitchell Journal: Pediatrics Date: 2004-07 Impact factor: 7.124
Authors: Betty A Poitra; Shirley Marion; Marilyn Dionne; Esther Wilkie; Paul Dauphinais; Marma Wilkie-Pepion; John T Martsolf; Marilyn G Klug; Larry Burd Journal: Neurotoxicol Teratol Date: 2003 Nov-Dec Impact factor: 3.763
Authors: Hein Odendaal; Eduard Kieser; Daan Nel; Lucy Brink; Carlie du Plessis; Coen Groenewald; Maristella Lucchini; William P Fifer; Michael M Myers Journal: Int J Gynaecol Obstet Date: 2019-08 Impact factor: 3.561
Authors: Richard D Goldstein; Carter R Petty; Sue E Morris; Melanie Human; Hein Odendaal; Amy Elliott; Deb Tobacco; Jyoti Angal; Lucy Brink; Hannah C Kinney; Holly G Prigerson Journal: Psychol Med Date: 2018-11-09 Impact factor: 7.723
Authors: DenYelle Baete Kenyon; Melissa Buffalo; Jessica Heinzmann; Michaela Seiber; Dorothy Castille; Amy Elliott Journal: Am Indian Alsk Native Ment Health Res Date: 2019
Authors: Matthew S Perzanowski; Khalil W Savary; Emilio Arteaga-Solis; Laura A Lautenbacher; Natalie H Brito; Virginia A Rauh; J David Nugent; Amy J Elliott; Michael M Myers; William P Fifer Journal: Am J Respir Crit Care Med Date: 2018-08-15 Impact factor: 21.405
Authors: Kimberly Dukes; Tara Tripp; Marian Willinger; Hein Odendaal; Amy J Elliott; Hannah C Kinney; Fay Robinson; Julie M Petersen; Cheryl Raffo; Dale Hereld; Coen Groenewald; Jyoti Angal; Gary Hankins; Larry Burd; William P Fifer; Michael M Myers; Howard J Hoffman; Lisa Sullivan Journal: Alcohol Date: 2017-06-15 Impact factor: 2.405
Authors: Theonia K Boyd; Colleen Anne Wright; Hein Odendaal; Amy J Elliott; Mary Ann Sens; Rebecca Dunn Folkerth; Drucilla J Roberts; Hannah Kinney Journal: Pediatr Dev Pathol Date: 2016-04-26
Authors: Natalie H Brito; Amy J Elliott; Joseph R Isler; Cynthia Rodriguez; Christa Friedrich; Lauren C Shuffrey; William P Fifer Journal: Dev Psychobiol Date: 2019-06-11 Impact factor: 3.038
Authors: Ping Ye; Jyoti Angal; Deborah A Tobacco; Amy R Willman; Christa A Friedrich; Morgan E Nelson; Larry Burd; Amy J Elliott Journal: Am J Prev Med Date: 2020-02-12 Impact factor: 5.043