The Kumagai Method: Feeding Techniques Using the Pigeon Baby Cleft Palate Bottle

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This article addresses an important topic in pediatrics, and adds to the feeding techniques currently available and used. It is well-written and flows in an organized sequence, appropriate for scholarly manuscripts. 
The literature review is well-developed and focuses on feeding techniques, commensurate with your study aim. 

This article provides a basic qualitative format that can lead to more sophisticated quantitative measurement of the technique. That is a common purpose of qualitative research and is exemplied here.  Qualitative research has small samples, however a sample of 3 RNs chosen for the interviews is extra small. That kind of sample could be appropriate for ethnography, case study research, or similar ones that are successful with one or very few people. The method of interviews coupled with a demonstration on a doll is less accurate than if a live infant had been selected. It could be very effective to film a child (with permission) to see the nurse actually executing this method. 

A strength of the article are the rich, descriptive paragraphs of the findings, and the discussion of each one. The identified themes are actually steps to the process. 

A weakness of the article is that the technique needs to be tested further, to establish scientific credibility. The final sentence mentions the need for scientific verification of the effectiveness of the technique. My suggestion is to have it earlier, in the discussion, to enable deeper dialogue. 

In summary, this article is like a case report, which was another method that could have been used. It provides detail that can impact feeding success in children with CLP, therefore does add to the knowledge on this topic. 

Comments on the Quality of English Language

There is an occassional errorr, very slight ones. Otherwise, it reads beautfully!

Author Response

AUTHORS’ RESPONSES TO REVIEWERS’ COMMENTS

Reviewer 1

Comment #1
Qualitative research has small samples, however a sample of 3 RNs chosen for the interviews is extra small. That kind of sample could be appropriate for ethnography, case study research, or similar ones that are successful with one or very few people.

Response: We would like to thank the reviewer for evaluating our manuscript and for the insightful comments. We agree that the phenomenological approach or ethnography would be appropriate for a small number of cases; however, we intended to describe the Kumagai method as an established and structured methodology, rather than as an individual experience. We recognize that your point is important and have already discussed this sample size issue in the Discussion section (line 339).

 

Comment #2
The method of interviews coupled with a demonstration on a doll is less accurate than if a live infant had been selected. It could be very effective to film a child (with permission) to see the nurse actually executing this method. 

Response: Thank you for proposing a more effective method. However, we considered that it could be difficult to explicitly explain this method by demonstrating it in actual children because it is unethical to repeatedly insert or remove a bottle from a child who wants to drink (or does not want to drink). We have limited this study to explaining the basic Kumagai method using dolls and have added the following explanation to the Discussion section as the scope for future research.

Lines 346–349:
“Moreover, demonstrations with a doll may not have replicated reality. It is necessary to observe the nursing skills of the participants in their daily nursing practice in real children and to investigate whether or not there are other techniques that have not yet been identified.”

 

Comment #3:
A weakness of the article is that the technique needs to be tested further, to establish scientific credibility. The final sentence mentions the need for scientific verification of the effectiveness of the technique. My suggestion is to have it earlier, in the discussion, to enable deeper dialogue. 

Response: The sentence explaining the need for a study to verify the effectiveness of the Kumagai method was shifted to the first paragraph of the Discussion (lines 301–305), as per your suggestion.

 

Comment #4:
In summary, this article is like a case report, which was another method that could have been used. It provides detail that can impact feeding success in children with CLP, therefore does add to the knowledge on this topic. 

Response: Thank you for your perceptive and positive comment. Practical cases series using this Kumagai method have recently been presented in Japanese. We have mentioned the content of this practice report as follows:

Lines 296–301:
“Ms. Kumagai recently presented a practical report in Japanese demonstrating the effectiveness of this method in actual children [29]. Implementation of the Kumagai method in children with CLP with ulceration of the nasal septum resulted in reduction of the ulcers in about 80% of children, and they could also drink the target amount of milk within 20 minutes [29].”

 

Comments on the Quality of English Language

There is an occassional errorr, very slight ones. Otherwise, it reads beautfully!

Response: Thank you very much for this positive feedback. We have had the entire manuscript undergo English proofreading to address minor issues.

Reviewer 2 Report

Comments and Suggestions for Authors

Review of the manuscript “The Kumagai Method: Feeding techniques using the Pigeon Baby Cleft Palate Bottle”

The objective of the study was to identify P-bottle feeding techniques performed by nurses who were experts on feeding 91 children with CLP and feeding difficulties. Overall, the manuscript is well-structured and clearly written, with a good command of English and clear representation of the aim of the paper.

The study methods are valid and reliable. The process of subject selection is clear. Variables are defined and measured appropriately. The authors employed appropriate statistical methods for the treatment of the data obtained. Text describes in detail the obtained values and their significance in drawing conclusions. Data are presented in an appropriate way. Relevance and importance of the obtained results are explained well in the discussion section. The results are discussed from multiple angles and placed into context without being overinterpreted.

Please consider the following:

·         Given the small sample size of only three nurses, how do you plan to address the potential limitations in generalizability, and are there any plans to expand the study to include more participants?

·         The study highlights the effectiveness of the Kumagai Method, but do you have any plans to conduct quantitative research to measure the impact of these techniques on feeding volume, weight gain, and ulcer prevention?

·         How does the Kumagai Method compare with other established feeding techniques for children with CLP, and are there any plans to conduct a comparative study?

·         What steps are being taken to standardize the Kumagai Method for broader clinical use, and how can this method be integrated into the training programs for nurses in other regions or countries?

Kindly incorporate the aforementioned details into your manuscript to enhance its overall quality.

In general, this article tackles an important subject and presents valuable results. While there are areas that could be strengthened, the article lays a solid foundation for future research in the field.

Author Response

AUTHORS’ RESPONSES TO REVIEWERS’ COMMENTS

Reviewer 2

Comment #1
Given the small sample size of only three nurses, how do you plan to address the potential limitations in generalizability, and are there any plans to expand the study to include more participants?

 

Response: We would like to thank the reviewer for evaluating our manuscript and for the insightful comments. We recognize that the small sample size is a major drawback of this study. However, we have no plans to conduct additional studies with a larger sample, as we have conducted a similar study surveying feeding techniques in approximately 500 nurses, but with inconsistent and contradictory results (Ueki, S.; Fujita, A.; Kumagai, Y.; Hirai, Y.; Tashiro, E.; Miyata, J. Bottle-feeding techniques for children with cleft lip and palate experiencing feeding difficulties. Int J Nurs Sci 2023, 10, 82-88; Reference No. 18).

Nevertheless, the generalizability of this method remains crucial. It is essential to evaluate the effectiveness of this method through a study with high methodological rigor. To emphasize this need, we have moved the discussion on the importance of such a study to the beginning of the Discussion section (lines 296–305), instead of at the end, where it was originally mentioned.

 

Lines 296–305:

“The other issue in this study is the effectiveness of the techniques of the Kumagai method. Ms. Kumagai recently presented a practical report in Japanese demonstrating the effectiveness of this method in actual children [29]. Implementation of the Kumagai method in children with CLP with ulceration of the nasal septum resulted in reduction of the ulcers in about 80% of children, and they could also drink the target amount of milk within 20 minutes [29]. Further clinical studies investigating this method with a larger sample of children are warranted to scientifically prove the extent to which the Kumagai method increases feeding volume and contributes to weight gain in children with CLP and feeding difficulties, and that it decreases the frequency of ulcer development compared to other techniques.”

 

 

Comment #2

The study highlights the effectiveness of the Kumagai Method, but do you have any plans to conduct quantitative research to measure the impact of these techniques on feeding volume, weight gain, and ulcer prevention?

 

Response: Yes, we agree that conducting quantitative research is very important. We have reported the effects of this Kumagai method in a small number of children [Kumagai, Y.; Hirai, Y.; Ueki, S.; Nagatomo, E.; Kogo M.; Tanaka, S. Verification of bottle-feeding (Kumagai method) for children with unilateral cleft lip and palate. J Jpn Cleft Palate Assoc 2024, 49, 110; Reference No. 29]. We have cited this practical report in the manuscript (Lines 296–301). We also stated that we will recruit a larger number of nursing personnel to test the effectiveness of the method (Lines 301–305).

 

 

Comment #3
How does the Kumagai Method compare with other established feeding techniques for children with CLP, and are there any plans to conduct a comparative study?

 

Response: Aside from the Kumagai method, no other feeding technique has been formally named or established. However, as mentioned earlier, Ms. Kumagai recently presented her work at an academic conference. According to the conference proceedings, the Kumagai method significantly reduced ulcers in most children who had developed them when using conventional feeding techniques commonly applied in clinical practice [Kumagai, Y.; Hirai, Y.; Ueki, S.; Nagatomo, E.; Kogo, M.; Tanaka, S. Verification of bottle-feeding (Kumagai method) for children with unilateral cleft lip and palate. J Jpn Cleft Palate Assoc 2024, 49, 110; Reference No. 29]. While this was not an experimental study and did not utilize an empirical setting or standardized evaluation methods, we believe it provides valuable preliminary evidence of the method's potential effectiveness. This report has been cited in the manuscript (lines 294–298).

 

 

Comment #4
What steps are being taken to standardize the Kumagai Method for broader clinical use, and how can this method be integrated into the training programs for nurses in other regions or countries?

 

Response: Thank you for the question. We have planned to get involved in developing social networking videos and smartphone apps to promote this method worldwide. A recent paper on social networking videos has been cited at the end of the Discussion section and added to the reference list.

 

Lines 352–359:

“Recently, many videos explaining feeding in children with CLP have been disseminated on social networking services (SNS); however, the contents have low validity [34]. To promote the global adoption of the Kumagai method, we released a brief video of the method on social media prior to this study [35,36]. We are now preparing new videos with more detailed explanations based on the results of this study. Additionally, we plan to develop a smartphone application in the future. We also believe that interventional studies utilizing these tools will be necessary to facilitate skill acquisition.”

Reviewer 3 Report

Comments and Suggestions for Authors

In this study, the P-bottle feeding techniques used by expert nurses for infants with CP/CL issues were examined. The study also explored how to use the bottle during feeding and how to respond to the infant's movement patterns. Managing and monitoring the feeding of infants with CP/CL is essential for reducing morbidity and mortality and ensuring surgeries are performed at the appropriate time. However, the article presents several limitations. The focus is primarily on bottle use. Information about the WHO-UNICEF breastfeeding support program, promoting direct breastfeeding from the mother's breast, and maintaining breast milk production should be provided.

Using visuals to demonstrate the placement of the nipple inside the mouth and the external holding positions could make the method clearer and more understandable. Visuals should be added. 

Information on the research design method [The qualitative research method used, such as phenomenology, ethnography, case study, grounded theory, or content analysis, should be specified], interview design (indept??), confidentiality, researcher position, and triangulation, reliability and validity has not been provided.

The results, Tables and discussion sections had similar sentences.

Line 246: Please explain “Hikkake-Nomashi”

Line 267-270 stated “After the child with CLP is born, a palatal obturator is made and fitted, and most children are able to drink without special technique. However, it takes about a week to create a palatal obturator. Meanwhile, the child must be accustomed to the P-bottle. If the child is not assisted to drink adequately, they will feed by tube or have intravenous infusion, and their natural ability to feed will degenerate.” The concern is that the passage does not address any issues related to breastfeeding or breast milk.

 

Line 328-331: “In particular, the nipple position was a new perspective: the nipple should be placed on the line in the middle of the tongue, and the depth of the nipple should not insert to the base of the nipple.” It seems there might be a mix-up between "nipple" and "tongue" in the sentence.

 

A preliminary study has been presented, which examines how a method, whose clinical effectiveness has not yet been demonstrated, is interpreted by three experienced practitioners. The clinical effectiveness of the developed methods should have been evaluated through a mixed-design study; this could have been easily conducted in a center where 400 infants are followed annually.

 

This study provides valuable insights into the feeding techniques used by expert nurses for infants with CP/CL. However, several limitations must be acknowledged. Therefore, the current article, with its existing constraints, may not meet the criteria for publication and could benefit from substantial revisions or additional supporting data.

Comments on the Quality of English Language

Proofreading is necessary

Author Response

AUTHORS’ RESPONSES TO REVIEWERS’ COMMENTS

Reviewer 3

Comment #1
The focus is primarily on bottle use. Information about the WHO-UNICEF breastfeeding support program, promoting direct breastfeeding from the mother's breast, and maintaining breast milk production should be provided.

Response: We would like to thank the reviewer for evaluating our manuscript and for the insightful comments. We agree with your perspective and believe that our paper would not be an obstacle to the promotion of breastfeeding. The following information was added to the Introduction and Discussion sections.

Lines 54-57 (Introduction)
“The World Health Organization (WHO) recommends that infants should be fully breastfed for the first six months and has presented a statement entitled “Ten Steps to Successful Breastfeeding” with recommendations for healthcare facilities worldwide [15].”

Lines 360–365 (Discussion)
“The present study does not explicitly promote bottle-feeding promotion; the WHO's 10 Steps to successful breastfeeding, revised in 2018, have added the following: "9. Counsel mothers on the use and risks of feeding bottles, teats and pacifiers" [15]. Breastfeeding has mutual benefits for the mother and child and should be the first priority. However, when this is not possible, the existence of alternative bottle-feeding techniques, such as the one detailed in this study, would provide support to mothers.”

 

Comment #2
Using visuals to demonstrate the placement of the nipple inside the mouth and the external holding positions could make the method clearer and more understandable. Visuals should be added. 

Response: Thank you for the effective recommendations. We have added Figures 1 and 2 depicting the correct and incorrect ways of placing nipple.

 

Comment #3
Information on the research design method [The qualitative research method used, such as phenomenology, ethnography, case study, grounded theory, or content analysis, should be specified], interview design (indept??), confidentiality, researcher position, and triangulation, reliability and validity has not been provided.

Response: We have added the detailed study design in the “Study design” subsection of the Methods (line 99) as follows:

“The present study employed a qualitative, descriptive research design.”

We used the thematic analytical method for analysis, which has already been described in line 140.

Moreover, we have added the following details to the “Data collection” subsection of the Methods (line 120) as follows:

“A semi-structured, in-depth interview….”

Further, the consideration not to identify individuals to ensure confidentiality was added to the “Ethical consideration” subsection (lines 160–162) as follows:

“In addition, data were managed by serial numbers to ensure that individuals could not be identified.”

Finally, the background of the researcher and the interview steps have been added in lines 135–137 as follows:

“The interviewer is a researcher (S.U.) with experience as a pediatric nurse in feeding children with CLP but was ignorant of the Kumagai method. Therefore, he proceeded with the interview while checking the meaning of each word said by the participant.”

 

Triangulation, reliability, and validity were achieved via the following process, detailed on lines 148–152:
“After analysis, the results were returned to the participants again for perusal to ensure that there were no discrepancies in each participant’s intended meaning, which achieved investigator triangulation and enhanced the validity of the findings. The results were confirmed again by researchers and participants six months after the analysis was completed to ensure reliability.”

 

Comment #4
The results, Tables and discussion sections had similar sentences.

Response: We have ensured that there is a minimal overlap across these sections.

 

Comment #5
Line 246: Please explain “Hikkake-Nomashi”

Response: Please note that we have added two new figures (Figures 1 and 2) and a new part, as follows:

Lines 192–199:
“In the case of unilateral CLP, the participants called this maneuver “Hikkake-Nomashi” (a Japanese word devised by nurses, which means feeding while hooking the nipple onto the palate), a method that allowed only half the nipple to be in contact with the palate area, whereas the other half remained untouched, such that the nipple was overhanging the palate (Figure 1). By employing this method, the child can squeeze half the nipple with the tongue to release milk. The other half of the nipple is not compressed; however, the nipple does not enter the cleft, thus avoiding damage to the mucous membranes and ulcer formation.”

 

Comment #6
Line 267-270 stated “After the child with CLP is born, a palatal obturator is made and fitted, and most children are able to drink without special technique. However, it takes about a week to create a palatal obturator. Meanwhile, the child must be accustomed to the P-bottle. If the child is not assisted to drink adequately, they will feed by tube or have intravenous infusion, and their natural ability to feed will degenerate.” The concern is that the passage does not address any issues related to breastfeeding or breast milk.

Response: Please note that we have added the following sentences to the pertinent text to address your concerns.

Lines 289–293:

“After birth, a palatal obturator is fabricated and fitted for children with CLP, and most children are able to drink without special bottle-feeding techniques [27] and achieve breastfeeding. However, it takes about a week to fabricate a palatal obturator. Meanwhile, children with CLP, who cannot create a negative pressure in the oral cavity and cannot be breastfed directly, must become accustomed to the P-bottle.”

 

Comment #7
Line 328-331: “In particular, the nipple position was a new perspective: the nipple should be placed on the line in the middle of the tongue, and the depth of the nipple should not insert to the base of the nipple.” It seems there might be a mix-up between "nipple" and "tongue" in the sentence.

Response: We have re-examined the sentences in the Results and Discussion sections, and we confirm that the terms “the middle of the tongue” and “the base of the nipple” accurately convey our intended meaning.

 

Comment #8
A preliminary study has been presented, which examines how a method, whose clinical effectiveness has not yet been demonstrated, is interpreted by three experienced practitioners. The clinical effectiveness of the developed methods should have been evaluated through a mixed-design study; this could have been easily conducted in a center where 400 infants are followed annually.
This study provides valuable insights into the feeding techniques used by expert nurses for infants with CP/CL. However, several limitations must be acknowledged. Therefore, the current article, with its existing constraints, may not meet the criteria for publication and could benefit from substantial revisions or additional supporting data.

Response: We fully recognize the need to demonstrate the clinical effectiveness of the Kumagai method in real patients. However, we believe it was first important to clarify the fundamental principles of the Kumagai method in a descriptive and categorical way. The Kumagai method is already being used in clinical practice, and a presentation on its application was recently given. Its clinical effectiveness is discussed in the first paragraph of the Discussion, with a citation of this report (lines 296–305). However, this report did not employ an empirical setting or standardized evaluation methods.

We acknowledge that the current study is not exhaustive on its own, but we plan to conduct a rigorous scientific empirical study on the Kumagai method in the future, and we hope you will review that work when it becomes available.

Lines 296–305
“The other issue in this study is the effectiveness of the techniques of the Kumagai Method. Ms. Kumagai recently presented a practical report in Japanese demonstrating the effectiveness of this method in actual children [29]. Implementation of the Kumagai Method in children with CLP with ulceration of the nasal septum resulted in reduction of the ulcers in about 80% of children, and they could also drink the target amount of milk within 20 minutes [29]. Further clinical studies investigating this method with a larger sample of children are warranted to scientifically prove the extent to which the Kumagai Method increases feeding volume and contributes to weight gain in children with CLP and feeding difficulties, and that it decreases the frequency of ulcer development compared to other techniques.”

Round 2

Reviewer 3 Report

Comments and Suggestions for Authors

The requested revisions have been sufficiently addressed.