Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol

Amy Sarah Ginsburg; Augusto Braima de Sa; Victoria Nankabirwa; Raimundo Co; Joanitta Murungi; Mi-Ok Kim; Rachel Brim; Flavia Namiiro; Olive Namugga; Dennis J. Hartigan-O’Connor; Susan B. Roberts; Valerie Flaherman

doi:10.1371/journal.pone.0263129

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Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol

Amy Sarah Ginsburg ,

Roles Conceptualization, Methodology, Supervision, Writing – original draft, Writing – review & editing

* E-mail: messageforamy@gmail.com

Affiliation University of Washington, Seattle, WA, United States of America

https://orcid.org/0000-0002-2291-2276

⨯
Augusto Braima de Sa,

Roles Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation International Partnership for Human Development, Bissau, Guinea-Bissau
⨯
Victoria Nankabirwa,

Roles Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliations Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda, Department of Global Public Health and Primary Care, Centre for Intervention Science in Maternal and Child Health (CISMAC), Centre for International Health, University of Bergen, Bergen, Norway
⨯
Raimundo Co,

Roles Investigation, Project administration, Supervision, Writing – review & editing

Affiliation International Partnership for Human Development, Bissau, Guinea-Bissau
⨯
Joanitta Murungi,

Roles Investigation, Project administration, Writing – review & editing

Affiliation Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda
⨯
Mi-Ok Kim,

Roles Methodology, Writing – review & editing

Affiliation Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, United States of America
⨯
Rachel Brim,

Roles Methodology, Writing – review & editing

Affiliation Department of Pediatrics, University of California, San Francisco, CA, United States of America
⨯
Flavia Namiiro,

Roles Investigation, Writing – review & editing

Affiliation Mulago Specialized Women’s and Neonatal Hospital, Kampala, Uganda
⨯
Olive Namugga,

Roles Investigation, Writing – review & editing

Affiliations Department of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda, Department of Global Public Health and Primary Care, Centre for Intervention Science in Maternal and Child Health (CISMAC), Centre for International Health, University of Bergen, Bergen, Norway
⨯
Dennis J. Hartigan-O’Connor,

Roles Methodology, Writing – review & editing

Affiliations Department of Medical Microbiology and Immunology and the California National Primate Research Center, University of California, Davis, CA, United States of America, Division of Experimental Medicine, University of California, San Francisco, CA, United States of America
⨯
Susan B. Roberts,

Roles Conceptualization, Methodology, Supervision, Writing – review & editing

Affiliation Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States of America
⨯
Valerie Flaherman

Roles Conceptualization, Funding acquisition, Methodology, Project administration, Supervision, Writing – original draft, Writing – review & editing

Affiliation Department of Pediatrics, University of California, San Francisco, CA, United States of America
⨯

Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol

Amy Sarah Ginsburg,
Augusto Braima de Sa,
Victoria Nankabirwa,
Raimundo Co,
Joanitta Murungi,
Mi-Ok Kim,
Rachel Brim,
Flavia Namiiro,
Olive Namugga,
Dennis J. Hartigan-O’Connor

Published: February 4, 2022
https://doi.org/10.1371/journal.pone.0263129

Reader Comments (29)

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22 Mar 2022
14:59 GMT
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Comment on the layout and update on the Petition Posted by PattiRundall on 22 Mar 2022 at 14:59 GMT
1 Response

08 Mar 2022
14:31 GMT
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Publisher's Note: Concerns Raised Posted by PLOS_ONE_Group on 16 Feb 2022 at 22:29 GMT
2 Responses

04 Mar 2022
17:38 GMT
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Medical study done on vulnerable populations Posted by rst.fleur on 04 Mar 2022 at 17:14 GMT
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02 Mar 2022
17:18 GMT
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Vulnerable Population Posted by ndahlquist on 02 Mar 2022 at 17:18 GMT
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28 Feb 2022
16:18 GMT
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The Scientific World need to re-evaluate the unethical flaws in the Flaherman protocol Posted by swatkins on 28 Feb 2022 at 16:18 GMT
1 Response

27 Feb 2022
06:15 GMT
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Follow up response to reader comments Posted by vflaherman on 19 Feb 2022 at 08:13 GMT
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27 Feb 2022
05:55 GMT
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The lack of scientific justification for this research Posted by aeglash on 27 Feb 2022 at 05:55 GMT
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19 Feb 2022
18:57 GMT
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This trial should not published Posted by esterken on 19 Feb 2022 at 18:57 GMT
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18 Feb 2022
23:44 GMT
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Trial has no local voices Posted by pbuchanan on 18 Feb 2022 at 23:44 GMT
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17 Feb 2022
20:59 GMT
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Ethics Posted by llangonamontanholi on 17 Feb 2022 at 20:59 GMT
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17 Feb 2022
19:13 GMT
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Need for a new ethics review and cancelation of this study and future safeguards for our vulnerable babies in Africa and around the world Posted by mwhoolery on 17 Feb 2022 at 19:13 GMT
1 Response

17 Feb 2022
16:11 GMT
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Author response to comments Posted by vflaherman on 17 Feb 2022 at 04:48 GMT
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17 Feb 2022
14:52 GMT
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Correction Posted by PattiRundall on 17 Feb 2022 at 14:52 GMT
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17 Feb 2022
14:48 GMT
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Please stis unethical trial Posted by PattiRundall on 17 Feb 2022 at 14:48 GMT
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17 Feb 2022
14:02 GMT
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The Ethics of trying out a product in a LMIC Posted by judyc on 17 Feb 2022 at 14:02 GMT
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16 Feb 2022
03:03 GMT
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Ethical Concerns Posted by lanatol on 16 Feb 2022 at 03:03 GMT
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15 Feb 2022
15:13 GMT
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Serious ethical concerns Posted by gchristakis on 15 Feb 2022 at 15:13 GMT
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15 Feb 2022
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Doubts about ethics Posted by acattaneo523 on 15 Feb 2022 at 14:48 GMT
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15 Feb 2022
13:18 GMT
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Unethical study Posted by rvianna538 on 15 Feb 2022 at 13:18 GMT
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15 Feb 2022
11:27 GMT
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Concern about the Ethical Approval Process for this research by Ginsberg et al Posted by callcutt on 15 Feb 2022 at 11:27 GMT
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15 Feb 2022
06:02 GMT
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Unethical Trial on African Babies : Why? Posted by Arun1696 on 15 Feb 2022 at 06:02 GMT
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15 Feb 2022
01:23 GMT
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Babies have human rights too DO NO HARM - Breast milk substitutes do harm if not medically indicated Posted by jstevens554 on 15 Feb 2022 at 01:23 GMT
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14 Feb 2022
20:51 GMT
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Questions regarding Ethical Approval and Conflicts of Interest in an infant feeding RCT being undertaken in Africa Posted by mherron417 on 14 Feb 2022 at 20:51 GMT
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13 Feb 2022
15:50 GMT
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How did this proposed experimentation study on our African babies, by Western universities and Western formula company get ethics approvals? Posted by mwhoolery on 13 Feb 2022 at 15:50 GMT

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