Nabulsi 

et al.
International Breastfeeding Journal (2022) 17:9
https://doi.org/10.1186/s13006-022-00452-1

RESEARCH Open Access

The inverted syringe technique

for management of inverted nipples
in breastfeeding women: a pilot randomized
controlled trial
Mona Nabulsi1*  , Rayan Ghanem2, Hanan Smaili1 and Ali Khalil2 

Abstract 
Background:  Women with inverted nipples may struggle with breastfeeding and may stop exclusive breastfeeding
before six months. The use of an inverted syringe to evert the nipples was successful in achieving high rates of infant
latching and exclusive breastfeeding in case series but has not been tested in clinical trials. This open label, paral-
lel group, randomized clinical trial investigated whether the use of the inverted syringe technique in women with
inverted nipples would increase exclusive breastfeeding rate at one month, as compared to standard care.
Methods/Design:  Between June 2018 and January 2020, healthy pregnant women (N=54) with grades 1 or 2
inverted nipples were randomly allocated to standard care or to an experimental group that used the inverted
syringe technique to evert the inverted nipple prior to every breastfeeding. The primary outcome measure was the
rate of exclusive breastfeeding at one month. Secondary outcomes included the rates of exclusive breastfeeding at
three and six months, any breastfeeding at one, three, and six months, nipple eversion, successful infant latching,
breastfeeding-associated complications, maternal satisfaction with breastfeeding, maternal quality of life, and adverse
events. Descriptive and bivariate analyses were conducted according to the intention to treat principle.
Results:  Participants in the experimental group were less likely to be exclusively breastfeeding at one (RR = 0.65,
95% CI: 0.44, 0.95; n = 47), and at three months (RR = 0.66, 95% CI: 0.47, 0.91; n = 45), or to practice any breastfeeding
at six months (RR = 0.54, 95% CI: 0.34, 0.87; n = 44). Only 14.3% of women in the experimental group complied with
the use of the inverted syringe during the first month. Breast pump and breastfeeding-associated complications were
more commonly reported in the control group (p < 0.05 for both). Both groups had similar rates of nipple eversion,
successful infant latching, and similar satisfaction with breastfeeding and quality of life issues.
Conclusion:  The inverted syringe technique was not associated with improvement in breastfeeding outcomes of
women with inverted nipples. Larger clinical trials are needed to confirm our findings.
Trial registration: ClinicalTrials.gov NCT03​529630; Registered May 8, 2018.
Keywords:  Inverted nipple, Breastfeeding, Inverted syringe technique

Background
The inverted nipple is an abnormality that is present in
*Correspondence: [email protected] 3% of females, with bilateral involvement in 86.8% of
1
Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, affected women [1]. A higher prevalence rate of 9.8% has
American University of Beirut, Beirut, Lebanon
Full list of author information is available at the end of the article been reported in pregnant women [2]. Nipple inversion

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Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 2 of 8

is mostly congenital but can be acquired secondary to day, and all women were breastfeeding by 28 days. Kesa-
inflammation such as in mastitis, or due to other con- ree, et al. [19] used an inverted syringe to apply negative
ditions such as cancer or breast surgery. Han and Hong pressure around the nipple in eight women. Seven infants
classified the severity of nipple inversion into three were latching by the first week and six were exclusively
grades based on the ability to manually pull out the nip- breastfeeding at six weeks. Although these non-surgical
ple and maintain its projection, and the extent of fibrosis interventions are simple and inexpensive, they may be
beneath it. Grade 1 inverted nipple has minimal fibrosis, complicated by adverse events such as nipple infection,
is easily pulled out manually with maintenance of good bleeding of the nipple or slipping of the rubber band into
projection. Grade 2 inverted nipple has moderate fibrosis the infant’s mouth. Except for the study of Alexander,
beneath it, can be pulled out manually but fails to main- et al., the previous reports were all case series and hence
tain projection. Grade 3 has severe fibrosis and inversion provide low quality evidence on the effectiveness of non-
and hence cannot be pulled out manually [3]. surgical interventions in improving breastfeeding rates
Women with inverted nipples often struggle with in women with nipple inversion. Moreover, these stud-
breastfeeding because of inadequate infant latching that ies had very small sample sizes and lacked power to draw
may lead to insufficient milk extraction, maternal frus- conclusions.
tration, and poor infant satiety, ultimately ending with In the present study we aimed to address the existing
premature termination of breastfeeding [4–7]. Early knowledge gap by conducting the first randomized con-
weaning from breastfeeding deprives the infant from trolled clinical trial to test whether the use of the inverted
his mother’s milk which is the ideal nutrition. It may syringe technique in healthy term pregnant women with
also reduce his chances of other health benefits such as inverted nipples would improve breastfeeding rates.
improved growth and development, reduced infections,
less risk of chronic diseases, better cognition, and higher Methods
intelligence quotient [8–12]. Mothers who discontinue Study design
breastfeeding or do not breastfeed may also be at higher This is an open-label, parallel arm, single-center, rand-
risks for certain cancers, chronic diseases such as obe- omized clinical trial that is reported in accordance with
sity, diabetes, and depression [8, 10, 13, 14]. The World the CONSORT 2010 statement guidelines for report-
Health Organization recommends exclusive breastfeed- ing parallel group randomized trials [21]. Its protocol
ing for the first six months and continuation of breast- was registered in ClinicalTrials.gov (NCT03529630) and
feeding with complementary foods until the infant is published in Trials [22]. The study was approved by the
two years of age [15]. Hence, it is important to provide Institutional Review Board of the American University of
women with inverted nipples with treatment options Beirut (Protocol PED.MN.15). Written informed consent
that will help them maintain breastfeeding and meet was obtained from all participants.
breastfeeding guidelines [15].
Treatment options for inverted nipples include surgical Participants
and non-surgical interventions. Historically, corrective Healthy pregnant women presenting to the Women’s
surgery was reserved for the severely invaginated nip- Health Center and the Delivery Suite of the American
ples (grade 3) that are not amenable to manual extrac- University of Beirut Medical Center, Beirut, Lebanon
tion, whereas non-surgical methods were indicated for were approached for enrolment in the study. Inclusion
less severe inversion (grades 1 or 2). Non-surgical inter- criteria were age at or above 18 years, completed at
ventions are several with variable rates of breastfeeding least 37 weeks of gestation, with one or two flat or
success and/or correction of nipple inversion [16–20]. inverted nipples of grades 1 or 2 according to Han and
Hoffman exercises and Woolwich breast shields for Hong’s classification of inverted nipples [3], intending
example were investigated in a clinical trial by Alexander, to breastfeed after delivery, and residing in Lebanon for

or breastfeeding rates [16]. The Niplette™ (Philips Avent,

et al., and were found to have no effect on nipple anatomy six months after delivery. Exclusion criteria were women
with grade 3 inverted nipples, breast conditions that may
Andover, MA), which was described in a case series of 22 affect the breast anatomy such as previous breast sur-
women by McGeorge [17] applies gentle negative suc- gery, not intending to breastfeed, any maternal or infant
tion over the nipple throughout the day and/or night to condition that may interfere with breastfeeding such as
extract it, with a reported success rate of 80% for nipple critical condition, congenital malformations like cleft lip
eversion and 100% for breastfeeding. Chakrabarti and and/or palate or esophageal atresia, and high-risk preg-
Basu [18] applied a rubber band at the nipple base of 19 nancies. Women with twin gestation were not excluded
women with flat or inverted nipples during breastfeed- if delivered at term. A trained research assistant verified
ing. Successful latching was present in 60% by the third inclusion criteria, explained the study’s objective and

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 Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 3 of 8

procedures, and obtained written informed consent from or complete eversion of the nipple, whichever hap-
all participants. pened first.
Secondary outcome measures were the rates of exclu-
Randomization and concealment sive breastfeeding at three and six months; mixed feeding
Participants were randomly allocated to the experimental at one, three and six months; nipple eversion (assessed by
or to the control arm in a 1:1 ratio. The random sequence the research assistant’s examination of the nipple at one
was computer-generated by an independent statistician month); successful latching on mother’s breast at one
and concealed by using sequentially numbered opaque month; and breastfeeding complications at one week, and
sealed envelopes. A participant’s allocation was revealed at one, three and six months. Breastfeeding-associated
only after the research assistant obtained her written complications were defined as the occurrence of sore nip-
informed consent. ple, mastitis, breast pain, bleeding, or engorgement in at
least one breast. Moreover, we assessed maternal satisfac-
Interventions tion with breastfeeding at one week using the validated
The trial was open label in view of the nature of the inter- Arabic Maternal Breastfeeding Evaluation Scale [23].
vention. Participants in the experimental group were This scale measures maternal perceived overall quality of
trained on the use of the inverted syringe on their first her breastfeeding experience. It has 26 items divided into
postpartum day in the privacy of their rooms by a trained three subscales: Infant Satisfaction/Growth, Maternal
research assistant. They were instructed to use a 10-cc Enjoyment/Role Attainment, and Lifestyle/Body. Item
inverted syringe before each breastfeeding. The mother responses are scored using a 5-point Likert-type scale
was shown how to position the base of the inverted ranging from 1 (strong disagreement) to 5 (strong agree-
syringe over the inverted nipple, and gently pull until ment). The sum of all item scores results in a minimum
the nipple was everted, maintaining it for one minute, of 26, and a maximum of 130 points, with higher score
after which the syringe was removed, and breastfeeding indicating higher maternal satisfaction with the breast-
started. The choice of the suction duration and syringe feeding experience. We also assessed maternal quality of
size were based on the initial description of the inter- life at one month using the validated Postpartum Quality
vention by Kesaree, et  al. [19]. Mothers were instructed of Life Questionnaire [24]. This instrument is a validated
that they may stop using the syringe if the nipple everted tool that measures the quality of life of mothers during
spontaneously and the infant was able to latch prop- the early postpartum period. It is composed of two parts
erly. The participants were also shown how to modify a with identical 39 items: satisfaction and importance, and
10-cc syringe into an inverted one in accordance with the has five domains: psychological/baby, socioeconomic,
report by Kesaree, et al. [19]. relational/spouse-partner, relational/family-friends, and
Participants in the control group received standard health and functioning. Items are scored according to a
advice on their infant nutrition, and on treatment of their Likert-type scale that ranges from 1 (very dissatisfied) to
inverted nipples by their primary physicians. Standard 6 (very satisfied). Scores are calculated by weighting each
advice on infant nutrition could include exclusive or par- satisfaction response with its paired importance with

er’s breast, or by using a nipple shield, Niplette™, inverted

tial breastfeeding either by direct latching on the moth- higher scores reflecting better quality of life.

syringe, expressed maternal milk using a pump, or the Study procedures

use of artificial milk instead of breastfeeding. At baseline, the research assistant collected data
on maternal age, parity, highest educational attain-
Outcome measures ment, employment, monthly household income, pre-
Our primary outcome measure was the rate of exclu- vious breastfeeding (Yes/No), grading of the inverted
sive breastfeeding at one month postpartum. Exclusive nipple(s), and the longest duration of previous breast-
breastfeeding was defined as giving the infant maternal feeding in multiparous women. This was defined as the
milk only, with no other food or drink including water, longest period of previous exclusive breastfeeding (in
but allowing oral rehydrating solutions, vitamins, min- months) during which a participant breastfed a daugh-
erals, or other medicines when needed [15]. We consid- ter/son. Moreover, on the first day postpartum, data
ered an infant to be exclusively breastfeeding whether were collected on the mode of delivery, gestational age,
breast milk was provided through direct latching on infant’s gender, birth weight, APGAR score, newborn
the mother’s breast or was expressed and offered by feeding (exclusive breastfeeding/artificial milk/mixed),
cup or bottle. Participants were instructed to continue sore nipple (Yes/No), use of devices to evert the nipple,
using the syringe until discontinuation of breastfeeding and compliance with the use of the syringe (experimen-
tal group only).

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Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 4 of 8

All participants were provided with a diary to docu- later. For other missing data we used the average value for
ment on daily basis in the first month information on the continuous variables, and random replacement to main-
type of infant nutrition (breast milk/formula), number tain proportions for categorical variables, as deemed
of artificial milk feedings, direct latching on the breast, appropriate. All analyses were conducted based on the

ple such as nipple shield, Niplette™ or syringe, as well as

use of any artificial device to correct the inverted nip- intention to treat principle using the Statistical Package
for Social Sciences version 24. A p value of <0.05 indi-
breastfeeding-associated complications. On the third and cates statistical significance.
seventh day postpartum, reminders about documenta-
tion in the diary were sent. In addition, participants in Results
the experimental group were contacted on weekly basis Baseline characteristics
to reinforce the use of the inverted syringe before each Between June 2018 and January 2020, 100 women meet-
breastfeeding. The diaries were collected at one month ing our inclusion criteria were approached for enrol-
(+ 10 days) by the research assistant who reassessed ment in the study. Of these, only 54 (54%) accepted to
the nipple eversion status, recorded the infant’s weight, participate in the trial. Due to the COVID-19 pandemic,
and administered the Postpartum Quality of Life Ques- the Institutional Review Board mandated stopping of all
tionnaire. At three and six months, information on the research activities requiring face-to-face contact with
infant’s weight and nutrition, as well as breastfeeding- participants in February 2020. Hence further recruitment
associated complications was collected by telephone. to the trial was not possible and the trial ended early
before reaching the intended sample size of 100 partici-
Sample size pants. Hence, we are reporting the trial as a pilot study.
The sample size was calculated to detect a difference of The flow of the participants through the trial is sum-
35% in the rate of exclusive breastfeeding at one month marized in the Fig. 1. In total, 9 of 54 (20%) participants
between the experimental and control groups, with 90% withdrew, a challenge that we anticipated a priori since
power, and 5% type I error. We hypothesized that 40% women with inverted nipples struggle during breastfeed-
of the participants in the experimental arm, and 5% in ing. Moreover, six participants stated that they lost their
the control arm would continue exclusive breastfeeding diaries. Hence, detailed information on their infants’
for one month. Therefore 25 women would need to be nutrition, breastfeeding-associated complications and
enrolled in each group to detect this difference. We antic- other challenges encountered during the first month was
ipated that 50% of participants would drop out during the unavailable. Missing data from diaries were not imputed.
trial because of the difficulties that women with inverted Hence, there were 39 participants with complete data-
nipples face during breastfeeding. Hence the sample size sets: 20 in the experimental and 19 in the control group.
was inflated to a total of 100 participants. However, we had information on breastfeeding outcomes
for 47 participants at one month, 45 participants at three
Statistical methods months, and 44 participants at six months which allowed
Continuous data were summarized as means (SD) or us to conduct the planned intent to treat analysis.
medians (IQR) as appropriate, and categorical data Our participants had a mean (SD) age of 30.3 (5.0)
as counts and proportions. Because of the small sam- years, and a mean (SD) gestational length of 38.3 (1.3)
ple size of the two groups, they were compared using weeks. The majority 36 (66.7%) were employed, attained
Mann Whitney test for the continuous variables and university education (n= 50; 92.6%), and had a monthly
Fisher’s Exact test for the categorical variables. Rates, household income above $1000 (n=45; 83.3%). Half
relative risk (RR) and 95% confidence intervals for exclu- (n=27) were delivered by Cesarean section, and most
sive breastfeeding and mixed feeding at one, three, and reported having support at home (n=50; 92.6%). Of the
six months were calculated using non-parametric tests. 54 participants initially recruited, 36 (66.7%) were primi-
We imputed missing data on breastfeeding outcomes by parous and 18 (33.3%) were multi-parous mothers hav-
using the last observation carried forward, if on last fol- ing a median (IQR) of 1.0 (1.0, 2.0) child, with a range of
low up the infant was reported to be on artificial milk, as 1 to 4 children. The median (IQR) number of breastfed
it was unlikely that those infants would be shifted back children among multi-parous mothers was 0.0 (0.0, 1.0)
to breastfeeding or mixed feeding after one month. For with a range of 0 to 3 children. Their median (IQR) long-
infants who on last follow up were on exclusive breast- est duration of previous breastfeeding was 3.0 (1, 7.5)
feeding or on mixed feeding, this information was not months. Only two (3.7%) participants reported having
imputed and was recorded as missing because those previous breast surgery. Flat nipples were present in 32
infants may have continued with the same type of nutri- (59.3%) right breasts and 27 (50%) left breasts, whereas
tion or changed to mixed feeding or artificial formula 10 (18.5%) right and 13 (24.1%) left nipples had grade 1

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 Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 5 of 8

Fig. 1  CONSORT flow diagram

inversion. Grade 2 inversion was present in only 2 (3.7%) mixed feeding was 67.5 (30.0, 120.0) days in the experi-
right and 5 (9.3%) left nipples. The prevalence of bilat- mental group, and 120.0 (10.0, 180.0) days in the control
eral nipple abnormality (flatness and/or inversion) was group. This difference however did not achieve statis-
70.4% (n=38). Because flat or grade 1 inverted nipples tical significance (p=0.237). Moreover, there were no
are milder abnormalities than grade 2 inverted nipples, significant differences in the rates of exclusive breast-
we merged them together in one group during analyses. feeding or any breastfeeding between participants with
There were no differences in any of the baseline charac- bilateral and unilateral nipple abnormality at any time
teristics of the two trial groups (Table 1). point (all p values > 0.05).
Of the 27 participants in the experimental group,
Breastfeeding outcomes only three (14.3%) reported using the inverted syringe
Table 2 summarizes the breastfeeding outcomes of both technique in at least 50% of breastfeeds during the first
groups. Participants in the control group were signifi- month, and none used it afterwards. Breastfeeding by
cantly more likely to be exclusively breastfeeding at one direct latching of the infant on the breast was reported
(RR = 0.65, 95% CI: 0.44, 0.95), and at three months (RR by 14 (59.1%) mothers in the experimental group, and
= 0.66, 95% CI: 0.47, 0.91). They also had higher rates 13 (66.7%) mothers in the control group (p = 0.607). The
of any breastfeeding at six months (RR = 0.54, 95% CI: nipple everted/inversion grade improved in 9 (42.5%) of
0.34, 0.87). The two groups had similar rates of exclusive the control and 6 (33.3%) of the experimental group (p =
breastfeeding at six months, and of any breastfeeding 0.742). By six months, more women in the control (n=10;
at one and three months. The median (IQR) duration of 41.7%), as compared to the experimental group (n=5;

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Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 6 of 8

Table 1  Baseline characteristics (N=54)

Variable Experimental Control P
n=27 n=27

Continuous variables
Median (IQR)
 Age (years) 29.0 (28.0, 33.0) 29.0 (26.0, 33.0) 0.883
 Gestational length (weeks) 38.0 (37.0, 39.0) 39.0 (38.0, 40.0) 0.231
 Number of children 1 (1, 2) 1 (1, 2) 0.378
 Number of breastfed children 0 (0, 1) 0 (0, 1) 0.465
 Longest previous breastfeeding (months)a 3.0 (1.5, 10.0) 3.0 (1.0, 9.0) 0.681
 Infant birth weight (grams) 3315 (2955, 3545) 3285 (3135, 3450) 0.647
 1-minute APGAR score 8 (8, 9) 9 (8, 9) 0.977
 5-minute APGAR score 9 (9, 10) 9 (9, 10) 0.788
Categorical Variables n (%)
 Caesarean delivery 16 (59.3) 11 (40.7) 0.276
 Male infant 14 (51.9) 13 (48.1) 1.000
 Infant admitted to NICU 1 (3.7) 1 (3.7) 1.000
 Female obstetrician 10 (37.0) 12 (44.4) 0.782
 Mother employed 17 (63.0) 19 (70.4) 0.773
 University education 24 (88.9) 26 (96.3) 0.610
 Monthly income >$1000 23 (85.2) 22 (81.5) 1.000
 Had support at home 25 (92.6) 25 (92.6) 1.000
Right nipple
 Inverted grade I 23 (85.2) 20 (74.1) 1.000
 Inverted grade 2 1 (3.7) 1 (3.7)
Left nipple
 Inverted grade I 20 (74.1) 20 (74.1) 0.352
 Inverted grade 2 1 (3.7) 4 (14.8)
 Bilateral nipple inversion 20 (76.9) 18 (66.7) 0.544
a
In multiparous women
IQR interquartile range, NICU neonatal intensive care unit

Table 2  Breastfeeding outcomes of trial participants to the experimental group (n=1; 4.8%) had one or more
Variable Experimental Control p RR (95% CI) breastfeeding-associated complication (p=0.012).
n/N (%) n/N (%)

EBF at 1 m 3/22 (13.6) 11/25 (44.0) 0.029 0.65 (0.44, 0.95)

Maternal breastfeeding satisfaction and quality of life
EBF at 3 m 1/21 (4.8) 9/24 (37.5) 0.012 0.66 (0.47, 0.91)
The two groups had similar scores on the Arabic Mater-
EBF at 6 m 1/20 (5.0) 5/24 (20.8) 0.198 0.83 (0.66, 1.05)
nal Breastfeeding Evaluation Scale and its three sub-
Any BF at 1 m 18/21 (85.7) 18/24 (75.0) 0.469 1.75 (0.50, 6.15)
scales: Infant Satisfaction/Growth, Maternal Enjoyment/
Any BF at 3 m 8/21 (38.1) 14/24 (58.3) 0.236 0.67 (0.38, 1.20)
Role Attainment, and Lifestyle/Body Image. They also
Any BF at 6 m 3/20 (15.0) 13/24 (54.2) 0.011 0.54 (0.34, 0.87)
had comparable scores on the Maternal Postpartum
EBF exclusive breastfeeding, m month, RR relative risk Quality of Life Questionnaire and its five domains:
Health functioning, Relational/family-friends, Socioeco-
nomic, Relational/husband-partner, and Psychological/
9.5%) were using a breast pump to express maternal milk Baby (Table 3).
(p = 0.020).
Breastfeeding-associated complications were reported Discussion
by a similar number of participants at one month: 9 In this study, we found that the use of the inverted syringe
(52.9%) in the experimental group versus 8 (42.1%) in the technique in women with inverted nipples was not asso-
control group, p = 0.739. However, at three months more ciated with improvement in breastfeeding rates at any
mothers in the control group (n=9; 37.5%) as compared time point during the first six months post-partum, nor

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 Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 7 of 8

Table 3  Scores of participants on Maternal Postpartum Quality of life Questionnaire and Maternal Breastfeeding Evaluation Scale
(N=49)
Variable Experimental Control p
n=22 n=24
Median (IQR) Median (IQR)

Maternal Postpartum Quality of Life

 Overall score 23.5 (21.4, 25.6) 23.1 (20.6, 25.2) 0.495
 Health functioning 22.4 (20.3, 24.4) 20.9 (17.9, 24.7) 0.166
 Relational/family-friends 22.6 (19.7, 23.9) 20.7 (16.8, 22.7) 0.113
 Socioeconomic 24.2 (22.3, 26.8) 25.9 (23.7, 27.9) 0.422
 Relational/husband-partner 27.6 (25.0, 30.0) 29.4 (25.2, 30.0) 0.486
 Psychological/Baby 23.2 (20.5, 26.7) 23.8 (17.0, 26.3) 0.852
Arabic Maternal Breastfeeding Evaluation Scale n=23 n=26 p
 Overall score 103.0 (99.0, 111.0) 105.5 (92.8, 112.3) 0.920
 Infant Satisfaction/Growth 37.0 (34.0, 39.0) 38.0 (34.8, 41.0) 0.393
 Maternal Enjoyment/Role Attainment 49.0 (46.0, 51.0) 48.5 (44.8, 53.0) 0.856
 Lifestyle/Body Image 20.0 (16.0, 21.0) 18.0 (14.8, 21.3) 0.231
IQR interquartile range

was it associated with higher maternal satisfaction with the inverted syringe technique. All previous reports
breastfeeding, or better quality of life. Moreover, the fact about the use of non-surgical techniques (including the
that few participants in the experimental group used the inverted syringe) in women with inverted nipples were
inverted syringe suggests that they may have found it to case series [17–19]. Hence the reported success rates in
be cumbersome or impractical to do with every breast- these studies may have been affected by inherent selec-
feeding. It is interesting to note that breastfeeding rates tion and/or confounding biases.
and breastfeeding-associated complications were higher Despite its limitations, we believe that it is important to
in the control group. These findings may be due to more report our findings as the study may be a stepping stone
women in the control group using breast pumps, as com- for further research on the effectiveness of non-surgical
pared to participants in the experimental group. treatments of inverted nipples in lactating mothers. It
Our study suffers from a major limitation related to its sheds light on the need for larger clinical trials in differ-
small sample size. To start with, recruitment into the trial ent settings, since acceptance of the intervention may
was challenging. About 50% of eligible women who were be different in other populations/settings. Qualitative
approached for enrolment declined, which may suggest research is also needed to explore the lack of acceptance
lack of acceptance of the intervention, negative previous of this technique in our context.
breastfeeding experiences that discouraged them from
experimenting with a new intervention, or lack of intent
Abbreviations
to breastfeed. A second contributor to the small sample SD: Standard deviation; IQR: Interquartile range; RR: Relative risk; CI: Confi-
size was the high attrition rate which was anticipated a dence interval; COVID-19: Coronavirus of 2019.
priori. Finally, the premature stopping of the trial man-
dated by the IRB during the COVID-19 pandemic was Supplementary Information
the major barrier to recruiting the desired sample size. The online version contains supplementary material available at https://​doi.​
The trial therefore is underpowered to detect a difference org/​10.​1186/​s13006-​022-​00452-1.
between the two groups, should a difference exist. The
differences we found in the rates of breastfeeding and Additional file 1. Anonymized dataset.
breastfeeding-associated complications should be inter-
preted with caution, as they may be due to chance. Due
to the small sample size, we did not conduct a multivari-
ate logistic regression analysis as planned in our proto-
col to examine the association between the breastfeeding Authors’ information
RG participated in this study as an academic requirement of the Fellowship
outcome and different predictors. and Residency Research Program (FRRP) at the authors’ University. The pre-
The strength of this study is that it is the only rand- liminary findings of the trial were presented in the University’s Research Open
omized clinical trial investigating the effectiveness of House on May 17, 2019 and was awarded the Best Poster Presentation.

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Nabulsi et al. International Breastfeeding Journal (2022) 17:9 Page 8 of 8

Acknowledgements 9. Victora CG, Horta BL, Loret de Mola CL, Quevedo L, Pinheiro RT, Gigante
We are thankful to all our participants for their valuable contribution to this DP, et al. Association between breastfeeding and intelligence, educa-
study. We are also thankful to Dr. Hani Tamim for his statistical advice. tional attainment, and income at 30 years of age: a prospective birth
cohort study from Brazil. Lancet Glob Health. 2015;3:e199-205.
Authors’ contributions 10. Victora CG, Bahl R, Barros AJD, Franҫa GVA, Horton S, Krasevec J, et al.
MN was responsible for the conception and design of the study, applied and Breastfeeding in the ­21st century: epidemiology, mechanisms, and
received grant for the study, analysed the data, and wrote the first and final lifelong effect. Lancet. 2016;387:475–90.
versions of the manuscript. RG participated in study design and writing of 11 Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breast-
the manuscript, HS participated in data collection and manuscript writing, feeding and childhood obesity: a meta-analysis. BMC Public Health.
AK participated in study design and manuscript writing. All authors read and 2014;14:1267.
approved the final manuscript. 12 Belfort MB, Rifas-Shiman SL, Kleinman KP, Guthrie LB, Bellinger DC,
Taveras EM, et al. Infant feeding and childhood cognition at ages 3 and
Funding 7 years. Effects of breastfeeding duration and exclusivity. JAMA Pediatr.
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Medicine Medical Practice Plan 11485.720.9999. The funding body had no role 13 Rameez RM, Sadana D, Kaur S, Ahmed T, Patel J, Khan MS, et al. Associa-
in the design of the study, collection, analysis, and interpretation of data or in tion of maternal lactation with diabetes and hypertension. A systematic
writing the manuscript. review and meta-analysis. JAMA Netw Open. 2019;2:e1913401.
14. Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, et al.
Availability of data and materials Breastfeeding and maternal health outcomes: a systematic review and
The dataset supporting the conclusions of this article is included within the meta-analysis. Acta Paediatr. 2015;104(Suppl 467):96–113.
article and its additional file. 15. The World Health Organization. The World Health Organization’s infant
feeding recommendation. Last accessed 2 June 2021. Available from:
http://​www.​who.​int/​nutri​tion/​topics/​infan​tfeed​ing_​recom​menda​tion/​
Declarations en/
16. Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of
Ethics approval and consent to participate breast shells and Hoffman’s exercises for inverted and non-protractile
This study was approved by the Institutional Review Board of the American nipples. BMJ. 1992;304:1030–2.
University of Beirut (Protocol PED.MN.15). Written informed consent was 17. McGeorge DD. The “Niplette ”: an instrument for the non-surgical correc-
obtained from all participants. tion of inverted nipples. Br J Plast Surg. 1994;47:46–9.
18. Chakrabarti K, Basu S. Management of flat or inverted nipples with simple
Consent for publication rubber bands. Breastfeed Med. 2011;6:215–9.
Not applicable. 19. Kesaree N, Banapurmath CR, Banapurmath S, Shamanur K. Treatment of
inverted nipples using a disposable syringe. J Hum Lact. 1993;9:27–9.
Competing interests 20. Fang Y, Zhu L, Bao L. The effect of multi-dimensional postpartum visit on
MN is associate editor of BMC Trials and editorial board member of BMC increasing the breastfeeding rate of parturients with inverted nipple: a
Pregnancy and Childbirth. Authors RG, HS, and AK declare that they have no randomized study. Ann Palliat Med. 2021;10:3078–85.
competing interests. 21. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT. statement:
updated guidelines for reporting parallel group randomized trials. Ann
Author details Intern Med. 2010;2010(152):726–32.
1
 Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, 22. Nabulsi M, Ghanem R, Abou-Jaoude M, Khalil A. Breastfeeding success
American University of Beirut, Beirut, Lebanon. 2 Present Address: Depart- with the use of the inverted syringe technique for management of
ment of Obstetrics and Gynecology, Faculty of Medicine, American University inverted nipples in lactating women: A study protocol for a randomized
of Beirut, Beirut, Lebanon. controlled trial. Trials. 2019;20:737.
23. Nabulsi M, Smaili H, Tamim H, Wahidi M, El-Jamal C. Validation of the Ara-
Received: 21 September 2021 Accepted: 22 January 2022 bic Maternal Breastfeeding Evaluation Scale (MBFES-A) among Lebanese
women. Int Breastfeed J. 2021;16:60.
24. Hill PD, Aldag JC, Hekel B, Riner G, Bloomfield P. Maternal postpartum
quality of life questionnaire. J Nurs Meas. 2006;14:205–20.

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