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

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 1, 2020

Primary Completion Date

November 1, 2021

Study Completion Date

May 15, 2022

Conditions
Inverted NippleExclusive 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

Trial Locations (1)

59030

Tekirdag Namık Kemal University, Tekirdağ

All Listed Sponsors
lead

Namik Kemal University

OTHER

NCT06978543 - The Effect of a Developed Device for Mother With Flat or Inverted Nipples | Biotech Hunter | Biotech Hunter