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NCT06978543
The Effect of a Developed Device for Mother With Flat or Inverted Nipples
NA trial testing A Prototype Device Developed for Flat or Inverted Nipples (DFIN) in Inverted Nipple in 32 participants. Completed in 15 May 2022.
1 November 2021
Quick facts
| Lead sponsor | Namik Kemal University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 32 |
| Start date | 1 November 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 15 May 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- A Prototype Device Developed for Flat or Inverted Nipples (DFIN)
- Modified injector
Conditions studied
- Inverted Nipple — all drugs for Inverted Nipple →
- Exclusive Breastfeeding — all drugs for Exclusive Breastfeeding →
Sponsor
Namik Kemal University
Who can join
Adults 18 to 40, female only, with Inverted Nipple or Exclusive Breastfeeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06978543
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06978543 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Namik Kemal University
- Last refreshed: 18 May 2025
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