Structured breastfeeding education for infants with nipple refusal
The Impact Of Structured Breastfeeding Education On Sucking Function, Breastfeeding Motivation, And Mother-Infant Attachment In Infants With Breast Refusal: A Randomized Controlled Trial
This test will see if a one-week, midwife-led breastfeeding education program plus 15 days of online support helps 1–6 month-old infants who have been refusing the nipple and improves mothers' breastfeeding motivation and bonding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kars, Kars) |
| Trial ID | NCT07496307 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll mothers of infants aged 1–6 months who have experienced nipple refusal for 3–30 days and randomize them to a structured breastfeeding education program or standard care. The intervention consists of daily one-hour individual or group education sessions for one week covering latch techniques, milk production strategies, skin-to-skin contact, bonding, and motivation, followed by 15 days of online support and daily observation forms. Outcomes including infants' sucking skills, maternal breastfeeding motivation, and mother-infant bonding will be measured at baseline and on day 16 post-intervention. The control group will receive routine medical care and an educational brochure after study completion.
Who should consider this trial
Good fit: Mothers who are literate, without significant pregnancy or postpartum complications, able to attend in-person sessions and online follow-up, and whose infants are 1–6 months old with 3–30 days of nipple refusal are ideal candidates.
Not a fit: Infants with serious congenital anomalies or health problems, or mothers with severe psychiatric or chronic illnesses or who cannot comply with sessions and follow-up are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help more infants latch and feed effectively, increase mothers' confidence and breastfeeding continuation, and strengthen mother-infant bonding.
How similar studies have performed: Previous breastfeeding education and support programs have shown improvements in latch, milk supply, and breastfeeding duration, but randomized trials specifically targeting acute nipple refusal are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria (Dahil Etme Kriterleri): Mothers with infants aged 1-6 months Mothers of infants who have experienced nipple refusal for 3-30 days Mothers who provide written informed consent Mothers without pregnancy or postpartum complications Mothers who are literate and able to understand the study questionnaires Exclusion Criteria: * Infants with serious congenital anomalies or health problems Mothers with severe psychiatric or chronic illnesses Any medical condition in the mother or infant that prevents participation Mothers who refuse to complete the study or cannot comply with the follow-up
Where this trial is running
Kars, Kars
- Kafkas University Training and Research Hospital — Kars, Kars, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Emel Güçlü Cihan, Assistant Professor — Kafkas University Training and Research Hospital
- Study coordinator: Emel güçlü Güçlü Cihan, Assistant Professor
- Email: emel_guclu4606@hotmail.com
- Phone: 03443004913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.