Impact of introducing a standardized nutrition protocol on very premature infants’ growth and morbidity

Apolline Wittwer; Jean-Michel Hascoët

doi:10.1371/journal.pone.0232659

Peer Review History

Original SubmissionJanuary 9, 2020
9 Jan 2020 Author Response Attachments Attachment Submitted filename: 200109 WITTWER et HASCOET Plos one highlight correction.doc https://doi.org/10.1371/journal.pone.0232659.r001
7 Feb 2020 Decision Letter - Harald Ehrhardt, Editor PONE-D-19-35465 Impact of introducing a standardized nutrition protocol on very premature infants’ growth and morbidity PLOS ONE Dear Dr. WITTWER, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. I kindly ask you to address all points raised by both reviewers in a revised version of the ms including a detailled point-by-point response to each comment addressing the changes in the revised version. Please pay special attention to the SDS and z-score discrepancies and the proper and detailled inclusion of congruencies and disparities of the presented results in comparison to the published literature. We would appreciate receiving your revised manuscript by Mar 23 2020 11:59PM. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). This letter should be uploaded as separate file and labeled 'Response to Reviewers'. 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The PLOS ONE style templates can be found at http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This paper has been improved by the responses the authors have made to the reviewer comments, and I am appreciative of their efforts. However, there are a few more issues which would improve the paper further if they were to be addressed. The main issue is that, whilst they have now added in something about the changes in SDS from birth in their groups (line 139-140), they have not shown this data properly, nor integrated well into the paper. It seems there were not significant differences between the groups with regard to change in SDS from birth, and this is an important finding. As change in SDS from birth takes into account the differences in birth weight in each group, the fact that the authors could not demonstrate a significant improvement in the fall in SDS from birth to each time point, means that their intervention perhaps was not as effective at improving growth as they suggest it is. The change in SSD is more meaningful that raw SDS, so for me this non-significant difference supersedes the significant findings between the two groups in terms of raw z score. The authors need to better integrate and acknowledge the new results in to the paper (as a table or figure) and need to comment more on this non-significant finding in the results. This is not to say that the work here is not important- they demonstrated that their intervention had a significant impact on nutrient delivery, and this is important. The fact it doesn’t to appear to have made an impact on growth may fit with their finding that compliance with the new practices were poor, and is again important and needs further thought and comment. In relation to this, the authors compared group using t-tests or mann-whitney tests. If the growth and nutrition data is normally distributed, then they should use linear regression where possible rather than t tests, as this would enable them to adjust for baseline factors between groups such as sex, gestational age and weight at birth. This may also impact on their results My other main comment, is that whilst the authors have now included some pertinent references of similar studies (Andrews et al. Rogerro et al and Rochow et al), they have only included these in the introduction and not the discussion, which needs to be addressed. In the discussion, the authors need to comment on how their findings are similar to or differ from these earlier studies, and where there are differences, what are they and why do the authors think this occurred? There other some other, more specific, minor issues which need to be addressed: Abstract- this is fine though the results section is packed with dense figures and is a little hard to read, The authors need to make their headlines clear here Line 73- this should read SDS and not DS. Also, WOG (week of gestation) would be better replaced with the term Post-conceptual Age (PCA). Figures 1 and 2 should also use SDS and not DS in the y axis labels Line 136- the authors still use the term ‘significantly more important’ and I’m not sure what they mean by this. Looking at the results I think they mean ‘significantly smaller’, but this needs to be amended Reviewer #2: The authors have addressed most of my comments as far as available. As with many retrospective studies some relevant data are missing which is addressed in the discussion. I have a few minor comments to be addressed. Page 11 line 209 I think it should read We speculate that lower protein intake may have a delayed maturation effect...... Page 11 line 218. I would add a sentence here that unfortunately there were no data available on respiratory support (echanical ventilation and/or CPAP). I expect that that would be the most important factor why longer doxapram was given? The references are still inconsistent including some french words and eg ref 33 is incomplete. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files to be viewed.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0232659.r002
Revision 1
26 Mar 2020 Author Response Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files As requested, we included the tables as part of the main manuscript Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ________________________________ 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policyhttp://www.plosone.org/static/policies.action#sharing requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ________________________________ 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ________________________________ 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This paper has been improved by the responses the authors have made to the reviewer comments, and I am appreciative of their efforts. However, there are a few more issues which would improve the paper further if they were to be addressed. The main issue is that, whilst they have now added in something about the changes in SDS from birth in their groups (line 139-140), they have not shown this data properly, nor integrated well into the paper. It seems there were not significant differences between the groups with regard to change in SDS from birth, and this is an important finding. As change in SDS from birth takes into account the differences in birth weight in each group, the fact that the authors could not demonstrate a significant improvement in the fall in SDS from birth to each time point, means that their intervention perhaps was not as effective at improving growth as they suggest it is. The change in SSD is more meaningful that raw SDS, so for me this non-significant difference supersedes the significant findings between the two groups in terms of raw z score. The authors need to better integrate and acknowledge the new results in to the paper (as a table or figure) and need to comment more on this non-significant finding in the results. This is not to say that the work here is not important- they demonstrated that their intervention had a significant impact on nutrient delivery, and this is important. The fact it doesn’t to appear to have made an impact on growth may fit with their finding that compliance with the new practices were poor, and is again important and needs further thought and comment. As requested, we added in the Results section additional Figures (Fig 3A for boys and Fig.3B for girls) to illustrate the delta z-score analysis; In addition, we developed the comments on this non-significant finding in the discussion. In relation to this, the authors compared group using t-tests or Mann-Whitney tests. If the growth and nutrition data is normally distributed, then they should use linear regression where possible rather than t tests, as this would enable them to adjust for baseline factors between groups such as sex, gestational age and weight at birth. This may also impact on their results As stated in the Method section, we tested the normality of the data with a Shapiro-Wilk test of normality. Unfortunately, the fit is poor for several variables and significant for one of them indicated a lack of normal distribution. Therefore it is not appropriate to perform a linear regression for these data. In addition, the difference observed between each time point is rather low which allow us to speculate that a linear regression would not show any significant correlation. Using weight z-score adjusted for sex may be considered as a substitute for the impact of sex, gestational age and post-natal age. The analysis of delta weight z-score from birth should cope for weight at birth. My other main comment, is that whilst the authors have now included some pertinent references of similar studies (Andrews et al. Rogerro et al and Rochow et al), they have only included these in the introduction and not the discussion, which needs to be addressed. In the discussion, the authors need to comment on how their findings are similar to or differ from these earlier studies, and where there are differences, what are they and why do the authors think this occurred? As requested, we developed the 3 studies whose findings are consistent with our own data in the discussion section of the manuscript. There other some other, more specific, minor issues which need to be addressed: Abstract- this is fine though the results section is packed with dense figures and is a little hard to read, The authors need to make their headlines clear here Line 73- this should read SDS and not DS. Also, WOG (week of gestation) would be better replaced with the term Post-conceptual Age (PCA). Figures 1 and 2 should also use SDS and not DS in the y axis labels Line 136- the authors still use the term ‘significantly more important’ and I’m not sure what they mean by this. Looking at the results I think they mean ‘significantly smaller’, but this needs to be amended All these points have been corrected. Reviewer #2: The authors have addressed most of my comments as far as available. As with many retrospective studies some relevant data are missing which is addressed in the discussion. I have a few minor comments to be addressed. Page 11 line 209 I think it should read We speculate that lower protein intake may have a delayed maturation effect...... Page 11 line 218. I would add a sentence here that unfortunately there were no data available on respiratory support (echanical ventilation and/or CPAP). I expect that that would be the most important factor why longer doxapram was given? All these points have been corrected and a sentence added in the discussion as requested The references are still inconsistent including some french words and eg ref 33 is incomplete. We thoroughly revised the referent format to make it consistent throughout the manuscript. We corrected and completed the incomplete reference. We apologize for that problem. 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?https://journals.plos.org/plosone/s/editorial-and-peer-review-process#loc-peer-review-history). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policyhttps://www.plos.org/privacy-policy. Reviewer #1: No Reviewer #2: No Attachments Attachment Submitted filename: renamed_24f03.docx https://doi.org/10.1371/journal.pone.0232659.r003
21 Apr 2020 Decision Letter - Harald Ehrhardt, Editor Impact of introducing a standardized nutrition protocol on very premature infants’ growth and morbidity PONE-D-19-35465R1 Dear Dr. WITTWER, We are pleased to inform you that you have carefully addressed all items raised and that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. 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With kind regards, Harald Ehrhardt Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: (No Response) Reviewer #2: The reviewers have addressed my remaining comments. I have no remaining comments except for the legend for figure 3A and B is now missing ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No https://doi.org/10.1371/journal.pone.0232659.r004
Formally Accepted
5 May 2020 Acceptance Letter - Harald Ehrhardt, Editor PONE-D-19-35465R1 Impact of introducing a standardized nutrition protocol on very premature infants’ growth and morbidity Dear Dr. Wittwer: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Harald Ehrhardt Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0232659.r005

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