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

NCT03529630 | Completed DMC

• 1 other identifier: PED.MN.15
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Inverted Nipple

Outcome Measures

Primary Outcomes (1)

• One month exclusive breastfeeding rate

  Proportion of mothers who are exclusively breastfeeding

  1 month postpartum

Secondary Outcomes (13)

• 3-month exclusive breastfeeding rate

  3 months postpartum

• 6-month exclusive breastfeeding rate

  6 months postpartum

• Nipple eversion rate

  1 month postpartum

• Successful latching

  1 month postpartum

• 1-month mixed feeding rate

  1 month postpartum

Study Arms (2)

Inverted syringe

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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. .

Interventions

Inverted syringe OTHER

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

Inverted syringe

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples
• Able to read and write
• 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 \[11\].

You may not qualify if:

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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (21)

• 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.

  PMID: 26792873 BACKGROUND

• 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.

  PMID: 25794674 BACKGROUND

• 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.

  PMID: 26869575 BACKGROUND

• 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.

  PMID: 25495402 BACKGROUND

• 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.

  PMID: 23896931 BACKGROUND

• 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.

  PMID: 22371471 BACKGROUND

• 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.

  PMID: 22895934 BACKGROUND

• 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.

  PMID: 14944774 BACKGROUND

• 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.

  PMID: 1873618 BACKGROUND

• 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.

  PMID: 10654681 BACKGROUND

• 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.

  PMID: 1586788 BACKGROUND

• 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.

  PMID: 8124566 BACKGROUND

• 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.

  PMID: 21214390 BACKGROUND

• 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.

  PMID: 8489719 BACKGROUND

• 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.

  PMID: 23295957 BACKGROUND

• 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.

  PMID: 7619250 BACKGROUND

• 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.

  PMID: 7619277 BACKGROUND

• 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.

  PMID: 17278340 BACKGROUND

• 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.

  PMID: 24428951 BACKGROUND

• 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.

  PMID: 35123525 DERIVED

• 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.

  PMID: 31842992 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 18, 2018
• Study Start: June 1, 2018
• Primary Completion: February 25, 2020
• Study Completion: July 15, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After December 2021.
• Access Criteria: Request data sharing from the principal investigator.

Locations

LE (1)