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

• ClinicalTrials.gov Identifier: NCT03529630
• Recruitment Status: Recruiting
• First Posted: May 18, 2018
• Last Update Posted: July 23, 2020
• Sponsor: American University of Beirut Medical Center
• Information provided by (Responsible Party): Mona Nabulsi, American University of Beirut Medical Center

Tracking Information

• First Submitted Date: May 8, 2018
• First Posted Date: May 18, 2018
• Last Update Posted Date: July 23, 2020
• Actual Study Start Date: June 1, 2018
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2018)

One month exclusive breastfeeding rate [ Time Frame: 1 month postpartum ]

Proportion of mothers who are exclusively breastfeeding

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 18, 2018)

• 3-month exclusive breastfeeding rate [ Time Frame: 3 months postpartum ]
  Proportion of mothers who are exclusively breastfeeding
• 6-month exclusive breastfeeding rate [ Time Frame: 6 months postpartum ]
  Proportion of mothers who are exclusively breastfeeding
• Nipple eversion rate [ Time Frame: 1 month postpartum ]
  Proportion of mothers with everted nipples
• Successful latching [ Time Frame: 1 month postpartum ]
  Proportion of infants with successful latching while breastfeeding
• 1-month mixed feeding rate [ Time Frame: 1 month postpartum ]
  Proportion of infants on mixed feeding
• 3-month mixed feeding rate [ Time Frame: 3 months postpartum ]
  Proportion of infants on mixed feeding
• 6-month mixed feeding rate [ Time Frame: 6 months postpartum ]
  Proportion of infants on mixed feeding
• Breastfeeding-associated complications [ Time Frame: 1 week postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 1 month postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 3 months postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 6 months postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Maternal satisfaction with breastfeeding [ Time Frame: 1 week postpartum ]
  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).
• Maternal quality of life [ Time Frame: 1 month postpartum ]
  Maternal quality of life assessed with the validated Postpartum Quality of Life instrument

Original Secondary Outcome Measures (submitted: May 8, 2018)

• 3-month exclusive breastfeeding rate [ Time Frame: 3 months postpartum ]
  Proportion of mothers who are exclusively breastfeeding
• 6-month exclusive breastfeeding rate [ Time Frame: 6 months postpartum ]
  Proportion of mothers who are exclusively breastfeeding
• Nipple eversion rate [ Time Frame: 1 month postpartum ]
  Proportion of mothers with everted nipples
• Successful latching [ Time Frame: 1 month postpartum ]
  Proportion of infants with successful latching while breastfeeding
• 1-month mixed feeding rate [ Time Frame: 1 month postpartum ]
  Proportion of infants on mixed feeding
• 3-month mixed feeding rate [ Time Frame: 3 months postpartum ]
  Proportion of infants on mixed feeding
• 6-month mixed feeding rate [ Time Frame: 6 months postpartum ]
  Proportion of infants on mixed feeding
• Breastfeeding-associated complications [ Time Frame: 1 week postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 1 month postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 3 months postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Breastfeeding-associated complications [ Time Frame: 6 months postpartum ]
  Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
• Maternal satisfaction with breastfeeding [ Time Frame: 1 week postpartum ]
  Maternal satisfaction with breastfeeding assessed with the validated Maternal Breastfeeding Evaluation Scale
• Maternal quality of life [ Time Frame: 1 month postpartum ]
  Maternal quality of life assessed with the validated Postpartum Quality of Life instrument

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
• Official Title: 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
• Brief Summary: 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Breastfeeding
• Inverted Nipple

Intervention

Other: Inverted syringe

Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.

Study Arms

• 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.
  Intervention: Other: Inverted syringe
• 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. .

Publications *

• 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. Review.
• Victora CG, Horta BL, Loret de Mola C, Quevedo L, Pinheiro RT, Gigante DP, Gonçalves 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.
• Victora CG, Bahl R, Barros AJ, França 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. Review.
• 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.
• 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. Review.
• Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD003517. doi: 10.1002/14651858.CD003517.pub2. Review.
• SKOOG T. An operation for inverted nipples. Br J Plast Surg. 1952 Apr;5(1):65-9.
• Terrill PJ, Stapleton MJ. The inverted nipple: to cut the ducts or not? Br J Plast Surg. 1991 Jul;44(5):372-7.
• Han S, Hong YG. The inverted nipple: its grading and surgical correction. Plast Reconstr Surg. 1999 Aug;104(2):389-95; discussion 396-7.
• 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.
• McGeorge DD. The "Niplette": an instrument for the non-surgical correction of inverted nipples. Br J Plast Surg. 1994 Jan;47(1):46-9.
• 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.
• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré 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.
• Leff EW, Jefferis SC, Gagne MP. The development of the Maternal Breastfeeding Evaluation Scale. J Hum Lact. 1994 Jun;10(2):105-11.
• 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.
• 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.
• 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, 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 8, 2018): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2021
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Lebanon

Administrative Information

• NCT Number: NCT03529630
• Other Study ID Numbers: PED.MN.15
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

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

• Responsible Party: Mona Nabulsi, American University of Beirut Medical Center
• Study Sponsor: American University of Beirut Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: American University of Beirut Medical Center
• Verification Date: July 2020