The Effect of a Developed Device for Mother With Flat or Inverted Nipples

Summary

Breast milk alone can meet all the elements necessary of babies during the first 6 months. However, some problems prevent breast milk from being taken, including concern about milk insufficiency, hyperlactation, clogged milk ducts, engorgement, mastitis, painful, injured/cracked nipples, flat or inverted nipples.

As there is insufficient nipple projection in mothers with flat or inverted nipples, it has been reported that babies have difficulty latching on to the breast and have problems breastfeeding. Also, it has been found that mothers with nipples shorter than 7 mm need more support. Many interventions are recommended to solve flat or inverted nipple problems.

In our study, a device developed for flat or inverted nipples was used by researchers. Thisa device developed for flat or inverted nipples was developed by researchers based on their experience and literature. This study was designed to evaluate the effects of the device developed for flat or inverted nipples for mother just already giving birth on nipple length, baby's attachment to the breast and breastfeeding duration, "LATCH Breastfeeding Assessment Tool" scores and and the duration of exclusive breastfeeding time in the first 6 months. The hypotheses of the study are as follows: (H1): Nipple length of mothers in the intervention gorup is longer. (H2): Babies in the intervention gorup would have a shorter attachment time on the breast. (H3): Babies in the intervention group have a longer duration of one breastfeeding. (H4): The LATCH breastfeeding diagnosis and evaluation score of the intervention group is higher. (H5): Babies in the intervention gorup have a longer exclusive breastfeeding time.

Conditions

• Inverted Nipple
• Exclusive Breastfeeding

Interventions

DEVICE

A Prototype Device Developed for Flat or Inverted Nipples (DFIN)

This is a non-commercial, researchers-developed prototype breastfeeding aid (DFIN) designed for mothers with flat or inverted nipples. Produced using 3D printing, the device is made of biocompatible material and is not commercially registered. Prior to its application in patients, official approval for use was obtained from the Turkish Medicines and Medical Devices Agency (TITCK). DFIN was developed based on clinical experience and literature. Previous studies showed that warming the breast increases nipple temperature and enhances milk production. DFIN contains a 150-200 mL reservoir of warm water (39-41°C) to apply heat directly. It is anatomically designed to fit the breast and is kept in place for 10 minutes. Then the piston in the DFIN is pulled, with the mother's maximum comfort.

DEVICE

Modified injector

The syringe method used routinely in the unit was applied by the researcher to mothers immediately after delivery. In this method, the thin part to which the needle is attached is cut with a sharp knife, the plunger is placed in this area and the syringe is applied to the flat or inverted nipple to create a vacuum

Sponsors & Collaborators

• Namik Kemal University

  lead OTHER

Principal Investigators

• Serap BALCI, PhD,Prof. · ISTANBUL UNİVERSİTY CERRAHPAŞA

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2021-11-01

Completion

2022-05-15

Countries

• Turkey (Türkiye)

Study Locations