Postpartum Depression & Breastfeeding

“Your mental health is more important to me right now than any of this.” I overheard this exact quote multiple times in one lactation consultation. It was verbiage that I wrote down, thinking, I could use this phrase with my patients. The mother, with a history of depression and anxiety, has a newborn at home and has recently noticed the depression and anxiety seeping back into her life. She’s crying in the shower and having a hard time connecting with her baby. She has noticed that a big source of mental – and physical – pain is related to feedings. She has nipple damage and pain with latching, so she has also been pumping. She knows that breastmilk has some amazing nutrients for her baby. And, she is sinking into depression and finding it very difficult to connect with her little one.

Towards the end of this particular consult, after over an hour of evaluation and conversation, the IBCLC said “It sounds like mental health right now is our primary focus.” She then went on to have a conversation with her patient about different options for going forwards, all the while reiterating, multiple times, how mom’s mental health is ‘more important than any of this’ – indicating infant feedings.

This is such a hard place for a mother to find herself.

I think most parents in this situation ask themselves this question:

Do I prioritize my baby by offering him breastmilk so that he get those benefits at the expense of my mental health? Or, do I prioritize myself, stop breastfeeding and let my baby miss out on all of the benefits of breastmilk?

This is the wrong question.

A more appropriate question may be…

Is there a way I can improve my mental health and my breastfeeding experience?

– or –

If I am left with only two options: my mental health or breastmilk feeding; What is the right choice for my family (my baby AND myself)?

Let’s dive into the research behind both of these questions and see if we can encourage a parent in this position to look at their situation from a different point of view.

Question 1: Is there a way I can improve my mental health and my breastfeeding experience?

Here are some ideas that may help both mom’s mental health and their breastfeeding experience. Notice I said experience and not exclusive breastfeeding journey.

  • Mom works with an appropriate provider to seek help for mental health. Maybe it’s counseling, maybe it’s medication, etc.
  • Maybe we brainstorm a way for mom to get exercise and sleep and good nutrients into her daily schedule.
  • Maybe they switch to exclusively pumping and bottle feeding.
  • Maybe they switch to exclusively breastfeeding; if mom has low supply or baby cannot get the calories needed for growth then we top off with formula or donor milk after breastfeeding.
  • Maybe they switch to formula feeding for calories, and breastfeed for comfort or for ‘desert’.
  • Maybe she exclusively pumps for 24-48 hours while we do all of the things to get mom’s nipples healed, and then they go back to breastfeeding instead of pumping.
  • Maybe they use a Supplemental Nursing System (SNS). Maybe they do not use SNS.
  • Maybe they breastfeed, but switch one feeding every night to a bottle. Partner gives baby the bottle and mom gets an uninterrupted 4-8 hours of sleep. She may sacrifice breastmilk production, but it may be worth it if Mom’s mental health improves and we keep close tabs on baby’s weight gain.
  • Maybe mom weans and they use donor human milk instead.

Here is some information to remind parents that even partial breast milk feeding has some amazing value:

Jump to this table from the American Academy of Pediatrics Breastfeeding and the Use of Human Milk policy statement from 2022 Table 2 (1.)

Seriously, jump to that website, glance at the chart, then come right back. Let me give you one example: Ever breastfeeding vs. never breastfeeding reduces the risk of otitis media (ear infection) by 33%. More vs. less breastfeeding reduce the risk of otitis media by 33%. Exclusive breastfeeding for 6 months reduces risk of ear infection by 43% compared to no breastfeeding at all (1.). This is a great example of how partial breastfeeding is STILL WORTH IT if we can improve mom’s mental health while we are at it.

Question 2: If I am left with only two options: my mental health or breastmilk feeding. What is the right choice for my family (my baby AND myself)?

There’s no doubt that breastmilk offers value to both mom and baby that they are not able to get with formula. That leaves us with the question: does the value (benefits) of breastmilk outweigh the risk of a maternal mental health disorder?

Jump to this policy statement from the American Academy of Pediatrics (2.) and go to the second section titled Impact on the Infant Dyad and Family.

Here’s a brief overview – Untreated maternal perinatal depression can lead to:

  • infant at risk for toxic stress and its consequences – it can impact infants social-emotional development, including:
    • Impaired social interaction
    • Delays in language, cognitive, and social-emotional development
  • Untreated PPD can lead to impaired parent-child interaction
  • Immediate impairment of PPD can…
    • hinder bonding, reciprocal interaction, and healthy attachment;
    • distort perception of the infant’s behavior
    • cause the mother to be less sensitive and attuned, indifferent, or more controlling
    • impair the mother’s attention to, and judgment for, health and safety.

An original investigation published in JAMA Psychiatry in 2018 (3.) looked at postnatal depression in relation to two outcomes: (1) the trajectory of later EPDS scores, up to 11 years postpartum, and (2) child outcomes, up to 18 years old. When the children were 3.5 years old they looked at behavioral problems. At 16 years old math scores were assessed from a national public exam taken at the end of high school in the UK. When the children were 18 years old depression was assessed using a self-administered computerized interview.

They found that persistent and severe postnatal depression substantially raises the risk for adverse outcome on all child measures: the behavioral assessment, the math scores, and child’s depression at 18 years of age. They also noted that women with persistent postnatal depression showed elevated depressive symptoms up to 11 years after childbirth. Peristent and severe meant that the women had an EPDS score of 17 or higher at both 2 months postpartum and 8 months postpartum.

If a mom comes to this question, breastmilk OR mental health. I think it is important that we educate them on what is currently known about the value of breastmilk for both mom and baby as well as the benefits of positive maternal mental health. This way, our families can make an informed decision based on their specific situation.

To circle back around, mom’s mental health is very important to both herself AND her baby. Can we, as lactation professionals, use this data to encourage parents to prioritize their mental health and, just maybe, reframe their question?

RESOURCES

1. Joan Younger Meek, Lawrence Noble, Section on  Breastfeeding; Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics July 2022; 150 (1): e2022057988. 10.1542/peds.2022-057988

2. F. Earls, Michael W. Yogman, Gerri Mattson, Jason Rafferty, COMMITTEE ON PSYCHOSOCIAL ASPECTS OF CHILD AND FAMILY HEALTH, Rebecca Baum, Thresia Gambon, Arthur Lavin, Lawrence Wissow; Incorporating Recognition and Management of Perinatal Depression Into Pediatric Practice. Pediatrics January 2019; 143 (1): e20183259. 10.1542/peds.2018-3259

3. Netsi E, Pearson RM, Murray L, Cooper P, Craske MG, Stein A. Association of Persistent and Severe Postnatal Depression With Child Outcomes. JAMA Psychiatry. 2018;75(3):247–253. doi:10.1001/jamapsychiatry.2017.4363

Prenatal Breastmilk Expression

Scenario 1: For 33 years I have had nipples and never once has anything come from them and, quite frankly, they have proven to be quite useless. Then I get pregnant, notice my breast get a little larger, nipples change color and change slightly in shape. But still, they’re quite useless and nothing ever leaks from them. This crying, tiny, hungry baby comes into the world who I have to keep alive. And I’m suppose to do that with only these useless nipples that I have never once seen anything come out of. Why would I trust that they can keep this hungry baby alive?

Scenario 2: same set up: 33 years of useless nipples then I get pregnant. Then at 37 weeks pregnant, I’m in the warm shower and I try hand expression for the first time. It takes a few minutes of seeing nothing – after all, it is my first time trying and most things takes practice to figure out. Then all of the sudden: there is a drop of colostrum! I keep expressing and it keeps flowing. I DO have breastmilk in there, these nipples ARE useful. A few weeks later my hungry baby latches and not only am I confident that there is colostrum in my breasts, but I am confident and comfortable hand expressing some colostrum to give to her after she nursed, or to help her latch, or to relieve my engorgement that first week.

Scenario 1 is the sentiment that I heard many moms express those first two days in the hospital.

Scenario 2 was my personal journey. I had been in the lactation field for 5 years prior to having my first child and even I was amazed when I saw those first drops of colostrum. Imagine being a first time mom who has had no experience with breastfeeding. This is why I find antenatal (prenatal) breastmilk expression so intriguing- I think it can be so empowering and set a mom up for a confident breastfeeding journey. Now the question is: is this research based or professional opinion?

Now this article is a Scoping Review …. Which I’ve come to learn means that it can tell me all of the studies out there regarding this topic: antenatal (prenatal) breastmilk expression. But, it does not address a specific question and it does not give me one combined result. Instead, it appears to give a good overview of what research has already been done on the subject.

The authors found 20 studies to include in this scoping review, ranging from 1946-2019. After critically appraising the individual studies they determined “This review demonstrates a lack of high-quality evidence on the effects of aBME [antenatal breastmilk expression] on maternal and newborn outcomes.” (1.)

The individual studies address a wide variety of outcomes that can come from expressing milk during pregnancy. What I am most intrigued to learn about is:

How does aBME impact maternal confidence?

How does aBME impact infant health/gestational age?

There were some studies that addressed these questions. One specifically was a randomized control trial that looked at NICU rates of infants whose mothers expressed prenatally starting at 36 weeks vs the control group. (7.) I dive into this in the “I’m still curious about” section of this post. Another couple of studies looked at the maternal experience of expressing milk during pregnancy, with various answers: it appears that some mothers found it confidence boosting while others were frustrated or worried about the volume of colostrum they were able to produce while pregnant. (5, 6).

The authors of our scoping review noticed that many of the studies were conducted in the past few years, indicating increased interest in the subject. They also had some insightful recommendations for future research. It appears to me, that while there are a couple good, quality studies regarding this topic, we are still in need of future research to verify the safety and efficacy of prenatal breastmilk expression for the practice to be considered ‘evidence-based’. Go look at this scoping review for yourself, and share your thoughts in the comments.

Interesting after thought: some of the studies that were performed started pregnant women expressing as early as 20 weeks gestation. Now, the studies that started women expressing this early were from the 1940’s and 1950’s. The authors of the scoping review do caution readers regarding the interpretation of the results from these studies, as they all ranked very low in their critical appraisal.

So, after reading this and learning what a scoping review is (see “What I Learned” section”), my question is: Does the one randomized control trial regarding antenatal breastmilk expression give us enough data to guide clinical practice?

I don’t know.

Here’s what I do know:

The study recruited 635 women with pre-existing or gestational diabetes from six different hospitals in Australia. The intervention group was assigned to express breastmilk twice a day starting at 36 weeks gestation, while the control group received ‘standard care’. There was no difference between these two groups when assessing the proportion of infant admission to the NICU. The authors reported “There is no harm in advising women with diabetes in pregnancy at low risk of complications to express breastmilk from 36 weeks’ gestation.” (7.)

The authors of the scoping review did a critical appraisal of the systematic review and found …

Found in “Additional File 3: Detailed Critical Appraisal of Included Studies” in the scoping review (1.)

So, from this randomized control trial they determined that expressing breastmilk during pregnancy, starting at 36 weeks, did not negatively impact the infants. My question: Is this a strong enough study to recommend antenatal breastmilk expression starting at 36 weeks for low risk pregnancies?

Fun fact: there is a second RCT in progress, but I could not find published results, yet. (4.) (8.)

Readers, commenters -what do you think? I’d love to learn more from you, please leave your credentials in the comments as this will help me and our fellow readers learn. I want to hear from you whether you’ve been in the research field for 30 years or if this is your first time reading a research paper.

What I learned about after reading this scoping review:

Scoping review vs systematic review vs meta analysis

Scoping reviews (also called scoping exercises or scoping studies) are a way to synthesize evidence, and are typically used to provide an overview or map of the evidence.

Scoping reviews have many ways in which they are useful. However, they do not ask a specific question and they do not adjust for bias; therefore, scoping reviews are typically not used to inform clinical practice. Scoping reviews can be helpful in the following ways: to identify knowledge gaps, scope a body of literature, clarify concepts or to investigate research conduct. (2.)

Both systematic reviews and meta analysis can be used to inform and guide clinical practice. They “generally provide the highest level of evidence in evidence-based medicine (EBM), supporting the development and revision of clinical practice guidelines, which are recommendations for clinicians when caring for patients with specific diseases and conditions.” (3.)

A systematic review is a summary of existing published studies on a specific topic and it addresses a clearly defined question. A systematic review may, or may not, include a meta analysis. (3.)

“Systematic reviews follow a structured and pre-defined process that requires rigorous methods to ensure that the results are both reliable and meaningful to end users. These [systematic] reviews may be considered the pillar of evidence-based healthcare [15] and are widely used to inform the development of trustworthy clinical guidelines [11, 16, 17].” (2.)

A meta analysis is a mathematically driven way to combine the results from various studies. It is “a quantitative statistical analysis combining individual results to estimate the common or mean effect.” (3.)

Resources

1. Foudil-Bey I, Murphy MSQ, Dunn S, Keely EJ, El-Chaâr D. Evaluating antenatal breastmilk expression outcomes: a scoping review. Int Breastfeed J. 2021 Mar 12;16(1):25. doi: 10.1186/s13006-021-00371-7. PMID: 33712049; PMCID: PMC7971107.

2. Munn, Z., Peters, M.D.J., Stern, C. et al.Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol 18, 143 (2018). https://doi.org/10.1186/s12874-018-0611-x

3. Myung SK. How to review and assess a systematic review and meta-analysis article: a methodological study (secondary publication). J Educ Eval Health Prof. 2023;20.24. doi: 10.3352/jeehp.2023.20.24

4. Demirci J. Prenatal video-based education and postpartum effects. n.d. https://clinicaltrials.gov/ct2/show/NCT04258709?cond=antenatal+breast+milk+expression&draw=2&rank=1. Accessed 11 Apr 2020.

5. Casey JRR, Mogg EL, Banks J, Braniff K, Heal C. Perspectives and experiences of collecting antenatal colostrum in women who have had diabetes during pregnancy: a North Queensland semistructured interview study. BMJ Open. 2019;9:e021513 https://doi.org/10.1136/bmjopen-2018-021513https://clinicaltrials.gov/ct2/show/NCT04258709?cond=antenatal+breast+milk+expression&draw=2&rank=1. .

6. Demirci JR, Glasser M, Fichner J, Caplan E, Himes KP. “It gave me so much confidence”: First-time U.S. mothers’ experiences with antenatal milk expression. Matern Child Nutr. 2019;15:e12824

7. Forster DA, Moorhead AM, Jacobs SE, Davis PG, Walker SP, McEgan KM, et al. Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. Lancet. 2017;389:2204– 13 https://doi.org/10.1016/S0140-6736(17)31373-9.

8. Demirci JR, Glasser M, Bogen DL, Sereika SM, Ren D, Ray K, Bodnar LM, O’Sullivan TA, Himes K. Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index ≥25: protocol for a randomized, controlled trial. Int Breastfeed J. 2023 Mar 16;18(1):16. doi: 10.1186/s13006-023-00552-6. PMID: 36927811; PMCID: PMC10019405.

The Flavor of Human Milk in relation to Mom’s Food Intake

This is a fun one: How maternal food choices alter the flavor of human milk.

Let’s dig in.

This 2019 Systematic Review addresses how flavors transfer to both the amniotic fluid during pregnancy, and breastmilk during the lactation period. (1.) We’ll solely focus on transfer to human milk. There were 3 different methods used to determine if flavors transferred to human milk:

1. Chemical analysis: this can indicate if volatiles of a flavor are present in breast milk.

2. Sensory analysis: this can indicate if volatiles of a flavor are present in breast milk and demonstrate that the volatile is at a concentration detectable by the human olfactory and taste systems.

3. Children’s behavioral response: “Behavioral responses of the children were often videotaped and then measured at a later date by trained study personnel who were often blinded to the hypothesis and conditions except when mothers were asked about their perceptions of whether their child liked or enjoyed the aroma or food that was compared between conditions.” Examples of responses that were assessed: feeding duration, time attached to the nipple, number of sucks, head orientation toward, mouthing, facial expressions of liking, amount consumed, mother’s perception of infant behavior and enjoyment during feeding. These responses were measured either hours after maternal ingestion, or days or months after repeated maternal ingestion. (1.)

15 studies were included in the systematic review regarding maternal diet during lactation.

Very specific flavors were studied. The authors noted that their conclusions were only applicable to the flavors that were looked at:

• “eucalyptus coincided with the timing when mothers could smell eucalyptus on their breath.”
• Mixed vegetable juices were tested only by children’s behavioral response after repeated maternal ingestion

One important thing to note is that “Conclusions cannot be drawn to describe the relationship between mothers’ diet during either pregnancy or lactation and children’s overall dietary intake.“ (1.) Which means two things:

  1. From this data we can NOT determine that baby will avoid human milk based on what mom ate. I do not want this to turn into a witch hunt if baby is avoiding breastfeeding, this information does NOT tell us to limit mom’s food choices.
  2. I want to theorize that if mom eats certain foods the child will be more likely to accept and eat those certain foods when they start eating solids because they are familiar with the flavor and know it to be a safe -not poisonous- option (think way, way back in the day when people were foraging for foods – maybe this helped children determine what was safe). But, we also can NOT jump to that conclusion with the information from this systematic review. Further studies would have to address that theory.

The wild thing is : there is moderate evidence to indicate that some flavors that moms eat will change the flavor of breastmilk! Human milk is so cool.

After reading this article a couple times, here’s a question I still have: How valid are the Sensory Test and the Behavioral Response? Are they accurately measuring flavor transfer?

Sensory Test: Most of the sensory tests seem to involve panelists who smelled samples of breastmilk and then answered questions about, or rated, the scent. The sensory panels included 6-13 adults, with one study using 5 lactating women to taste their own breastmilk.

Children’s Behavioral Response: Here are some examples of behaviors that were assessed to determine if a child/infant recognized a flavor:

  • Feeding duration
  • Time attached to the nipple
  • Number of sucks
  • Head orientation toward
  • Mouthing
  • Facial expression
  • Amount consumed
  • Mother’s perception of infant behavior and enjoyment during feeding

My guess is that these behaviors could be modified for a number of different reasons, not simply in recognition to a flavor. How did they narrow down the independent variables to determine that these responses were in relation to flavor recognition and not say, time of day when mom’s supply might be lower or higher? I do think the fact that their responses were recorded then analyzed by trained study personal would help reduce the subjectiveness of the evaluations.

It is confidence boosting to see that some of these flavors (alcohol, garlic, carrot, caraway, eucalyptus, fish oil, and fennel-anise-caraway tea) were analyzed by more than one method. For example, alcohol flavor was tested by chemical analysis, sensory analysis and children’s behavioral response. It is also interesting that the timing tended to be consistent as well, regardless of the method used: “The timing of the observed differential behavioral responses coincided with the timing when sensory panels judged the milk to have altered flavor (20, 21,23, 25).” (1.)

The authors of this systematic review did give some studies, like the randomized controlled trials, higher consideration while taking into account the flaws/concerns of other studies. On page 1023S under internal validity, they thoroughly discuss the strong studies in comparison to the studies that received less weight due to possible bias. (1.)

Commenters: What do you know that I don’t? Hit me with your thoughts to my question in the comments. I want your comments whether you’ve been in the research field for 30 years or whether this is the first paper you’ve ever read. By including your credentials in your comment, that helps me and our readers learn together.

What exactly do the authors mean when they say “Conclusion statements related to diet during lactation and flavor transfer and infant detection were determined to be moderate in strength”?

Take a look at this table:

(2.)

Pretty self explanatory.

This table came from the paper titled “Systematic review methods for the Pregnancy and Birth to 24 Months Project” (2.) Our systematic review that we are discussing today stemmed from the USDA’s Nutrition Evidence Systematic Review team as part of the Pregnancy and Birth to 24 Months Project. Within this project they created a series of systematic reviews and this table came from their paper that discusses the methods they used when creating this series of systematic reviews.

Resources:

  1. Joanne M Spahn, Emily H Callahan, Maureen K Spill, Yat Ping Wong, Sara E Benjamin-Neelon, Leann Birch, Maureen M Black, John T Cook, Myles S Faith, Julie A Mennella, Kellie O Casavale, Influence of maternal diet on flavor transfer to amniotic fluid and breast milk and children’s responses: a systematic review, The American Journal of Clinical Nutrition, Volume 109, Issue Supplement_1, March 2019, Pages 1003S–1026S, https://doi.org/10.1093/ajcn/nqy240
  2. Obbagy JE, Spahn JM, Wong YP, Psota TL, Spill MK, Dreibelbis C, Gungor DE, Nadaud P, Raghavan R, Callahan EH, et al. Systematic review methodology used in the Pregnancy and Birth to 24 Months Project. Am J Clin Nutr 2019;109(7):698S−704S.

A pilot study comparing traditional flange fit to a new small-size flange fit.

It is exciting to think that there may be new methods for those who struggle with pumping. I’m cautiously optimistic.

Suzanne Sanders here, IBCLC for another article review.

This pilot study “Flange Size Matters: A Comparative Pilot Study of the Flange FITS Guide Versus Traditional Sizing Methods.” was published in November 2024 in a peer reviewed journal. (1)

Before we jump to the results, let’s talk about the method. 36 participants were measured and fitted with two different flange sizes. One flange was chosen based on the Flange FITS method (which is a new, smaller-sized fitting) and one flange was chosen based on the fit instructions from their specific pump manufacturer (standard fitting). For one week, they pumped at least 3 times (averaged 4.62 times) using the standard flange size, and for one week they pumped at least 3 times (averaged 4.71 times) using the smaller flange size. Half the participants were randomly assigned to pump the first week with the standard fit and the following week with the smaller fit, while the other half of the participants did the opposite. They pumped with their own double-electric, non-wearable breast pump. They were instructed to pump roughly the same time of day, at least 2 hours after their last pumping or nursing session.

The study found that those using the standard flange had less milk output and less comfort than when they used the smaller flange.

What I found fascinating were these two graphs: Figure 4 and Figure 5.

Figure 4 (1)

Figure 4 shows the patients’ reported comfort level. At the end of the week the participant pumped with the standard fit flange, they submitted one comfort rating, and at the end of the week they pumped with the smaller fit flange they submitted another comfort rating. The rating of 5 is ‘very comfortable or feels like nothing’ while the rating of 3 is ‘tolerable’. The average comfort rating for the standard size was 3.3, while the average comfort rating for the smaller fit was 4.5. For your in-the-workforce parent, or exclusively pumping parent, who has to pump multiple times a day, I imagine moving them up 1.2 points on the comfort scale could make a big difference in their breastfeeding journey.

Figure 5 (1)

Figure 5 is also worth a look; this is the change in milk yield between the smaller fit (portrayed by the orange square) and standard fit (portrayed by the blue circle). What I really appreciate about this visual is the nuance amongst individual participants. The mean milk yield for the smaller fit was 153.2 grams, and the mean milk yield for the standard fit was 138.2 grams. You can see in this image that some participants noticed a decent increase when using the smaller fit, while some barely noticed a difference and some noticed a decrease in milk yield.

This study highlights the importance of a flange fitting being “an individualized process led by participant reports of comfort and milk yield.” I think Figures 4 and 5 support this idea. In the supplementary material for this article, you will find a brief guide about how to find the flange sizing for the Flange FITS model. What I find most fascinating about this method is how personalized it is to the individual. It takes trial and error in an appointment and collaboration between lactation professional and the pumping parent. They try multiple different flanges to find which size both produces the best milk sprays and feels the best. My biggest takeaway from this research article is just how personalized and nuanced it is to find the best flange for the individual.

What is important to remember is this is a pilot study, the first of its kind with a relatively small pool of participants. To my understanding, these results need to be replicated by ideally a larger and longer study before we can actually change our current practice and call it ‘evidence-based’. (See my below section What I Learned). Also worth mentioning – there is a very specific method for how the ‘smaller fit flange’ was chosen; it’s called the “Flange FITS” and the guide is free. Hint: it involves actually trying a few flanges out with the patient while they are pumping and collaborating with the patient, so if you’re curious about how to choose the smaller size for your patient: find the guide.

I’d love to hear your thoughts on the article after you read it – post in the comments below and let us know your credentials. I want your input whether you’ve been in the research field for 30 years or if this is your first time reading a research article.

What I Learned : Pilot Studies

I did some digging to learn what a pilot study actually means and what a pilot study can reveal. From my readings, a pilot study is not intended to address a hypothesis. So, pilot studies, in general, are not designed to ask the question ‘Does this intervention work?’ It instead addresses the question ‘Can we perform this experiment?’ When reading and interpreting a pilot study, that’s a HUGE difference. The pilot study can be very helpful when creating a full-scale study by helping to catch and reduce errors and problems that may be encountered in the full-scale study. (3)

One article I read states:

“Pilot studies should not be used to test hypotheses about the effects of an intervention. The “Does this work?” question is best left to the full-scale efficacy trial, and the power calculations for that trial are best based on clinically meaningful differences. Instead, pilot studies should assess the feasibility/acceptability of the approach to be used in the larger study, and answer the “Can I do this?” question.” (2)

The intention is for the nipple tip to ‘glide against the sides of the [flange] tunnel’. Is this going to increase the risk of nipple damage? In this study, there were no reported injuries, but they followed up with the participants after only 1 week of pumping (per flange). What length of follow-up time is needed to determine the safety of this new method?

One other question: In the supplementary material, The Flange FITS Guide states “A thin layer of coconut oil or nipple balm on the bend of the flange can increase comfort.” Do we have any evidence that applying oil or balm to the flange affects -or does not affect- the expressed milk that ends up in the bottle?

References

1. Anders LA, Mesite Frem J, McCoy TP. Flange Size Matters: A Comparative Pilot Study of the Flange FITSTM Guide Versus Traditional Sizing Methods. Journal of Human Lactation. 2024;41(1):54-64. doi:10.1177/08903344241296036

2. “Pilot Studies: Common Uses and Misuses” NIH National Center for Complementary and Integrative Health. Accessed 5/1/2025. Last Updated 5/1/2025. https://www.nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses

3. Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 2015 Oct 20;314(15):1561-2. doi: 10.1001/jama.2015.10962. PMID: 26501530; PMCID: PMC4917389.