Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women

Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women: a Study Protocol for a Randomized Controlled Trial

Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. This open-label randomized clinical trial aims to investigate the effectiveness of the use of the inverted syringe technique on exclusive breastfeeding success in women with inverted nipples, as compared to standard of care.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Inverted Nipple
• Intervention / Treatment: Other: Inverted syringe

Detailed Description

Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Its benefits to infants and their mothers are many including protection from infections, certain malignancies and chronic diseases, as well as improved growth, development, cognition and intelligence for children. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. The main treatment of severely inverted nipples is surgical sectioning of the lactiferous ducts at the expense of breast's function. Several conservative measures have also been used for the less severe (grades 1 and 2) inverted nipples such as application of Hoffman Exercises and Woolwich Breast Shields, which have failed to prove their worth. The modified syringe technique is a conservative means for the correction of inverted nipples that was reported in a single case series of 8 women, with high success rates in infant latching (7/8) and exclusive breastfeeding (6/8). It is a simple, inexpensive, portable, safe, and easily learned method that can be performed by mothers as often as required.

This open-label randomized clinical trial aims to investigate the effectiveness of the use of inverted syringe on the 1-month exclusive breastfeeding rate in women with inverted nipples. We hypothesize that in women with grades 1 and 2 inverted nipples, the use of the modified syringe technique soon after delivery, as opposed to the standard of care, will significantly improve breastfeeding rates at 1 month postpartum. We will recruit 100 healthy women at ≥37 weeks of gestation with grades 1 or 2 inverted nipples from the Women's Health Center and the obstetrics outpatient department at AUBMC. They will be randomly allocated to a control group (standard of care) or to the intervention group (inverted syringe). Data will be collected at baseline (socio-demographic variables, inverted nipple grading) and at 1, 3, and 7 days postpartum about infant feeding method, and adverse events. Mothers will be contacted at 1, 3 and 6 months regarding infant feeding method, maternal satisfaction, infant's weight gain and adverse events. The association between breastfeeding success at 1 month and the use of the inverted syringe will be investigated using multivariate regression models. Findings from this study, if positive, will provide much needed evidence for a safe, affordable, readily available and simple intervention to treat inverted nipples and improve breastfeeding practice among affected women.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples
2. Able to read and write
3. Singleton or twin pregnancy An inverted nipple is defined as a condition in which the nipple is pulled inward into the breast instead of pointing outward, classified according to Han and Hong [11].

Exclusion Criteria:

1. Women with grade 3 inverted nipples
2. Previous breast surgery affecting the breast anatomy
3. High risk pregnancies
4. Medical conditions that could interfere with breastfeeding such as critical maternal condition
5. Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip &/or palate
6. Women choosing artificial milk as their preferred infant nutrition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inverted syringe; Participants in this arm will use of the inverted syringe before each breastfeeding starting from the first feed after delivery and continued as long as needed by the mother.	Other: Inverted syringe; Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
No Intervention: Standard of care; Participants in the control group will receive standard medical care as dictated by their obstetricians. Any advice regarding infant nutrition or treatment of inverted nipples will be left to the primary physician, including possible use of the inverted syringe technique. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One month exclusive breastfeeding rate	Proportion of mothers who are exclusively breastfeeding	1 month postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month exclusive breastfeeding rate	Proportion of mothers who are exclusively breastfeeding	3 months postpartum
6-month exclusive breastfeeding rate	Proportion of mothers who are exclusively breastfeeding	6 months postpartum
Nipple eversion rate	Proportion of mothers with everted nipples	1 month postpartum
Successful latching	Proportion of infants with successful latching while breastfeeding	1 month postpartum
1-month mixed feeding rate	Proportion of infants on mixed feeding	1 month postpartum
3-month mixed feeding rate	Proportion of infants on mixed feeding	3 months postpartum
6-month mixed feeding rate	Proportion of infants on mixed feeding	6 months postpartum
Breastfeeding-associated complications	Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement	1 week postpartum
Breastfeeding-associated complications	Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement	1 month postpartum
Breastfeeding-associated complications	Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement	3 months postpartum
Breastfeeding-associated complications	Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement	6 months postpartum
Maternal satisfaction with breastfeeding	Maternal satisfaction with breastfeeding assessed with the validated Maternal Breastfeeding Evaluation Scale (MBFES). The scale measures the overall maternal perceived quality with the breastfeeding experience. The scale has a Cronbach's alpha of 0.93. It is composed of 3 subscales: maternal enjoyment/role attainment, infant satisfaction/growth and lifestyle/body image. The corresponding Cronbach's alphas of the subscales are 0.93, 0.88 and 0.80 respectively. The overall score may range from 30 (least satisfied) to 150 (most satisfied).	1 week postpartum
Maternal quality of life	Maternal quality of life assessed with the validated Postpartum Quality of Life instrument	1 month postpartum

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Publications and helpful links

General Publications

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
• Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
• Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
• Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
• Victora CG, Horta BL, Loret de Mola C, Quevedo L, Pinheiro RT, Gigante DP, Goncalves H, Barros FC. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. 2015 Apr;3(4):e199-205. doi: 10.1016/S2214-109X(15)70002-1.
• Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014 Dec 13;14:1267. doi: 10.1186/1471-2458-14-1267.
• Belfort MB, Rifas-Shiman SL, Kleinman KP, Guthrie LB, Bellinger DC, Taveras EM, Gillman MW, Oken E. Infant feeding and childhood cognition at ages 3 and 7 years: Effects of breastfeeding duration and exclusivity. JAMA Pediatr. 2013 Sep;167(9):836-44. doi: 10.1001/jamapediatrics.2013.455.
• Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD003517. doi: 10.1002/14651858.CD003517.pub2.
• SKOOG T. An operation for inverted nipples. Br J Plast Surg. 1952 Apr;5(1):65-9. doi: 10.1016/s0007-1226(52)80008-6. No abstract available.
• Terrill PJ, Stapleton MJ. The inverted nipple: to cut the ducts or not? Br J Plast Surg. 1991 Jul;44(5):372-7. doi: 10.1016/0007-1226(91)90152-a.
• Han S, Hong YG. The inverted nipple: its grading and surgical correction. Plast Reconstr Surg. 1999 Aug;104(2):389-95; discussion 396-7. doi: 10.1097/00006534-199908000-00010.
• Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples. BMJ. 1992 Apr 18;304(6833):1030-2. doi: 10.1136/bmj.304.6833.1030.
• McGeorge DD. The "Niplette": an instrument for the non-surgical correction of inverted nipples. Br J Plast Surg. 1994 Jan;47(1):46-9. doi: 10.1016/0007-1226(94)90117-1.
• Chakrabarti K, Basu S. Management of flat or inverted nipples with simple rubber bands. Breastfeed Med. 2011 Aug;6(4):215-9. doi: 10.1089/bfm.2010.0028. Epub 2011 Jan 8.
• Kesaree N, Banapurmath CR, Banapurmath S, Shamanur K. Treatment of inverted nipples using a disposable syringe. J Hum Lact. 1993 Mar;9(1):27-9. doi: 10.1177/089033449300900127.
• Leff EW, Jefferis SC, Gagne MP. The development of the Maternal Breastfeeding Evaluation Scale. J Hum Lact. 1994 Jun;10(2):105-11. doi: 10.1177/089033449401000217.
• Riordan JM, Woodley G, Heaton K. Testing validity and reliability of an instrument which measures maternal evaluation of breastfeeding. J Hum Lact. 1994 Dec;10(4):231-5. doi: 10.1177/089033449401000416.
• Hill PD, Aldag JC, Hekel B, Riner G, Bloomfield P. Maternal Postpartum Quality of Life Questionnaire. J Nurs Meas. 2006 Winter;14(3):205-20. doi: 10.1891/jnm-v14i3a005.
• Nabulsi M, Hamadeh H, Tamim H, Kabakian T, Charafeddine L, Yehya N, Sinno D, Sidani S. A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial. BMC Public Health. 2014 Jan 15;14:36. doi: 10.1186/1471-2458-14-36.
• Nabulsi M, Ghanem R, Smaili H, Khalil A. The inverted syringe technique for management of inverted nipples in breastfeeding women: a pilot randomized controlled trial. Int Breastfeed J. 2022 Feb 5;17(1):9. doi: 10.1186/s13006-022-00452-1.
• Nabulsi M, Ghanem R, Abou-Jaoude M, Khalil A. Breastfeeding success with the use of the inverted syringe technique for management of inverted nipples in lactating women: a study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):737. doi: 10.1186/s13063-019-3880-8.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PED.MN.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Sharing of anonymized IPD is possible upon request from the principal investigator after 1 year from publication of the study.
• IPD Sharing Time Frame: After December 2021.
• IPD Sharing Access Criteria: Request data sharing from the principal investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No