The Effects of a New Wireless Non-Adhesive Cardiorespiratory Monitoring Device on the Skin Conditions of Preterm Infants

Round 1

Reviewer 1 Report

Dear Doctor Flores,

I have an honor to review your article “Effects of a new wireless non-adhesive cardiorespiratory monitoring device on skin condition of preterm infants”.

The article is aimed to the study of skin condition during prolonged wearing and removing cardiorespiratory monitoring device for neonates (Bambi-Belt), in compare to standard adhesive electrodes.

The article is written in good scientific language, and a good methodological justification of the work is given, the conclusions correspond to the aims of the study. However, I would like to draw your attention to a few places in your article. These remarks do not detract from the merits of the work:

in line 60-62, the sentence seems long, overloaded, and difficult to read because of the dashes;

in line 259-260, 262-263, the sentences also look overloaded, maybe they should be divided into chats and simplified;

In lines 270-271, the sentence seems cumbersome because of the two dashes.

Section 6 looks like it was forgotten to be removed from the text (empty).

 Please kindly pay attention to these remarks.

Dear Doctor Flores,

I have an honor to review your article “Effects of a new wireless non-adhesive cardiorespiratory monitoring device on skin condition of preterm infants”.

The article is aimed to the study of skin condition during prolonged wearing and removing cardiorespiratory monitoring device for neonates (Bambi-Belt), in compare to standard adhesive electrodes.

The article is written in good scientific language, and a good methodological justification of the work is given, the conclusions correspond to the aims of the study. However, I would like to draw your attention to a few places in your article. These remarks do not detract from the merits of the work:

in line 60-62, the sentence seems long, overloaded, and difficult to read because of the dashes;

in line 259-260, 262-263, the sentences also look overloaded, maybe they should be divided into chats and simplified;

In lines 270-271, the sentence seems cumbersome because of the two dashes.

Section 6 looks like it was forgotten to be removed from the text (empty).

 Please kindly pay attention to these remarks.

Author Response

To:         Jackson Wang, Editor Sensors

Veldhoven, 8-2-2023

Dear Editor,

Hereby we send you the revised version of our manuscript titled “Effects of a new wireless non-adhesive cardiorespiratory monitoring device on skin condition of preterm infants.”

We would like to thank you and the reviewers for the review of our manuscript and the helpful comments, which improved the manuscript. We have addressed all comments and suggestions in our point-by-point response.

We hope the revised version meets your expectations and we are looking forward to hear the reviewers’ and your opinion.

On behalf of the co-authors, sincerely,

Hendrik Niemarkt, MD PhD

Pediatrician Neonatologist

Maxima Medical Centre Veldhoven, The Netherlands

Reviewer 1:

I have an honor to review your article “Effects of a new wireless non-adhesive cardiorespiratory monitoring device on skin condition of preterm infants”. The article is aimed to the study of skin condition during prolonged wearing and removing cardiorespiratory monitoring device for neonates (Bambi-Belt), in compare to standard adhesive electrodes. The article is written in good scientific language, and a good methodological justification of the work is given, the conclusions correspond to the aims of the study.

We thank the reviewer for the comment.

However, I would like to draw your attention to a few places in your article. These remarks do not detract from the merits of the work:

in line 60-62, the sentence seems long, overloaded, and difficult to read because of the dashes;

We thank the reviewer for the comment and agree with the issues on this sentence. We altered the sentence accordingly. Page 2, line 61-64.

in line 259-260, 262-263, the sentences also look overloaded, maybe they should be divided into chats and simplified;

We agree with the reviewer and adjusted the paragraph accordingly. Page 8, line 258-262.

In lines 270-271, the sentence seems cumbersome because of the two dashes.

We agree with the reviewer and adjusted the paragraph accordingly. Page 8, line 269-275.

Section 6 looks like it was forgotten to be removed from the text (empty).

We thank the reviewer making us aware of this omission. We removed section 6.

Please kindly pay attention to these remarks.

Author Response File: Author Response.pdf

Reviewer 2 Report

1.Is there a clear rationale for the choice of the 10-day monitoring period (in line 18), and were there specific criteria for selecting preterm neonates in the study?

2.Given that the Bambi Belt is described as a disposable device (in line 126). Are there plans or considerations for future reusable versions, considering environmental sustainability?

3.Could the authors provide visual evidence or data from the study mentioned, demonstrating the non-inferiority of heart rate monitoring with the Bambi Belt compared to standard ECG with adhesive electrodes?

4.The discussion mentions three non-serious adverse skin events reported during the study, two of which were related to the belt. Could the authors provide additional information on the nature of these adverse events and how they were specifically related to the use of the Bambi Belt?

5.The discussion references a feasibility and monitoring study where no adverse events were reported (in line 274). Could the authors discuss any differences in study design or patient population between the current study and the feasibility and monitoring study that more accurate explain the discrepancy in adverse event reporting?

Author Response

Reviewer 2:

1.Is there a clear rationale for the choice of the 10-day monitoring period (in line 18), and were there specific criteria for selecting preterm neonates in the study?

We thank the reviewer for this question. This study assessing skin condition, was performed in the patients that were included for the monitoring study in the Maxima Medical Centre.  After the 24-h period during which the monitoring took place, the infants kept wearing the belt until a total study period of 10 days. During the whole period skin assessment took place. This length of the study period was chosen arbitrarily in order to detect skin effects when wearing it long term. In order to avoid methodological issues with a longer study period such as disappearance of need of cardiorespiratory monitoring or transfer to another ward we did not chose an even longer period. Future implementation studies should investigate the effects when wearing the belt during the whole stay on the ward. We addressed this at page 9, line 285-289.

2.Given that the Bambi Belt is described as a disposable device (in line 126). Are there plans or considerations for future reusable versions, considering environmental sustainability?

We agree with the reviewer that a reusable monitoring device would be preferable in order to avoid waste. However, to our best knowledge, a reusable option for cardiorespiratory monitoring in general is not available at the moment. We think it is important question for prospective clients to ask the company.

3.Could the authors provide visual evidence or data from the study mentioned, demonstrating the non-inferiority of heart rate monitoring with the Bambi Belt compared to standard ECG with adhesive electrodes?

This study focuses on skin effects of the Bambi Belt. Non-inferiority in heart rate monitoring was demonstrated in another paper in Pediatric Pulmonology to which we refer.

4.The discussion mentions three non-serious adverse skin events reported during the study, two of which were related to the belt. Could the authors provide additional information on the nature of these adverse events and how they were specifically related to the use of the Bambi Belt?

The reviewer makes an important point. The skin events consisted of fugacious redness at the location of the belt. The events did not require medical intervention. However all events were related to malpositioning (twisting) of the belt with contact loss of the electrodes. By study design, the Bambi belt was set to idle during the skin study period. This  was done to avoid double alarms of both the standard monitoring and the Bambi belt during this prolonged period. Therefore, the nursing staff was not immediately made aware of electrode contact loss and malpositioning of the belt and could not resolve this issue, as would have taken place in daily practice with a functioning belt. We addressed this in the discussion, page 8, line 269-275.

5.The discussion references a feasibility and monitoring study where no adverse events were reported (in line 274). Could the authors discuss any differences in study design or patient population between the current study and the feasibility and monitoring study that more accurate explain the discrepancy in adverse event reporting?

We thank the reviewer for this question. At first, during the longer skin assessment study monitoring and alarming function of the belt was disabled. Therefore, in case of twisting of the belt, with contact loss of one of the electrodes, the nursing staff was not alarmed, and did not immediately react to malpositioning of the belt as would be the case during the feasibility and monitoring studies. Immediate replacement of the belt to correct position would have prevented these adverse events in our opinion. Second, the monitoring and feasibility studies were short (maximum 24h). This longer skin assessment study (10 days), increased the chances of finding adverse skin events. We addressed this at page 8 line 269-276 and page 9, line 285.

Reviewer 3 Report

Itching and irritation of the skin, contacting with wearable devices is a common adverse effect preventing prolonged monitoring in some people. Such a problem is even more a challenge when the task is monitoring surveillance of preterm infants. Therefore, reported advantages of reviewed non-adhesive cardio-respiratory monitoring device for a vulnerable population is a valuable improvement facilitating prolonged monitoring of cardio-respiratory functions in preterm infants.

The advantage of the study is that skin conditions after wearing a tested novel non-adhesive Bambi Belt was compared against the standard monitoring system in the same babies during the similar duration and timing of wearing.

Results appear conclusive and properly validated. There are just a few issues:

Side-effects were controlled for the factor of gestational age, however, did the authors consider associated medical conditions of preterm babies or factors that can be related with medical conditional of mother, or parents. Could it be that presence of a definite medical condition is linked to more likely caused skin condition in an infant while wearing monitoring device?

The authors reported “When the belt was removed more than one time a day, skin assessment was only performed once. For the standard adhesive electrodes, no scheduled moment was defined for removal. They were only removed when it was deemed clinically necessary and only at this time skin condition was assessed” (P.3., L. 104-107). Therefore, two more questions: 1. when skin assessment was only performed once, was it always the same time (as certain physiological processes of skin may have a relationship with circadian factors), 2. In several cases the belt had to be removed several times per day. Have authors tested whether such events were random or associated with a particular time of day?

Section “Patents” is just a remaining part of the journal’s main text template, should be removed as the authors did not provide their own information.

Author Response

Reviewer 3:

Itching and irritation of the skin, contacting with wearable devices is a common adverse effect preventing prolonged monitoring in some people. Such a problem is even more a challenge when the task is monitoring surveillance of preterm infants. Therefore, reported advantages of reviewed non-adhesive cardio-respiratory monitoring device for a vulnerable population is a valuable improvement facilitating prolonged monitoring of cardio-respiratory functions in preterm infants. The advantage of the study is that skin conditions after wearing a tested novel non-adhesive Bambi Belt was compared against the standard monitoring system in the same babies during the similar duration and timing of wearing. Results appear conclusive and properly validated.

We thank the reviewer for the comments.

There are just a few issues:

Side-effects were controlled for the factor of gestational age, however, did the authors consider associated medical conditions of preterm babies or factors that can be related with medical conditional of mother, or parents. Could it be that presence of a definite medical condition is linked to more likely caused skin condition in an infant while wearing monitoring device?

As visible skin lesions were an exclusion criterion for the study. No infants with overt medical skin conditions were included. Therefore, caution must observed in infants with visible skin lesions or with already clinically fragile skin due extreme prematurity (postmenstrual age  <26 wks), congenital skin disease or skin infection. We added this in the discussion. Page 8, line 277-280.

The authors reported “When the belt was removed more than one time a day, skin assessment was only performed once. For the standard adhesive electrodes, no scheduled moment was defined for removal. They were only removed when it was deemed clinically necessary and only at this time skin condition was assessed” (P.3., L. 104-107). Therefore, two more questions: 1. when skin assessment was only performed once, was it always the same time (as certain physiological processes of skin may have a relationship with circadian factors), 2. In several cases the belt had to be removed several times per day. Have authors tested whether such events were random or associated with a particular time of day?

We thank the reviewer for this question. Although not specifically studied in this population, circadian rhythms may have impact on the skin. Belt opening was mostly performed during morning rounds when the infants was weighed. At this time-point, skin assessment took place. The assessment of the skin on the adhesive electrode sites was only performed as this was deemed clinically necessary (in order to avoid frequent adhesive electrodes removals). Those were also mostly performed during morning rounds when indication for monitoring was considered not indicated any more by the attending physician. Therefore it is not suitable in this study population to investigate circadian skin effects. We addressed this issue in the discussion. Page 9, line 281-284.

Section “Patents” is just a remaining part of the journal’s main text template, should be removed as the authors did not provide their own information

We thank the reviewer making us aware of this omission. We removed the paragraph.