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NCT03503500
Laid-back Breastfeeding in Hospital Setting
NA trial testing Laid-back breastfeeding in Breastfeeding in 208 participants. Completed in 6 December 2018.
14 August 2018
Quick facts
| Lead sponsor | IRCCS Burlo Garofolo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 208 |
| Start date | 28 March 2018 |
| Primary completion | 14 August 2018 |
| Estimated completion | 6 December 2018 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Laid-back breastfeeding
- Standard care — full drug profile →
Conditions studied
- Breastfeeding — all drugs for Breastfeeding →
Sponsor
IRCCS Burlo Garofolo — full company profile →
Who can join
Adults 15 to 55, female only, with Breastfeeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes. The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Support for healthy breastfeeding mothers with healthy term babies.
Gavine A, Shinwell SC, Buchanan P, Farre A, et al · · 2022 · cited 84× · PMID 36282618 · DOI 10.1002/14651858.cd001141.pub6 -
Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial.
Milinco M, Travan L, Cattaneo A, Knowles A, et al · · 2020 · cited 25× · PMID 32248838 · DOI 10.1186/s13006-020-00261-4
Verify or expand the search:
- PubMed search for NCT03503500
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breastfeeding
Currently open trials in the same condition.
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Other IRCCS Burlo Garofolo trials
Trials by the same sponsor.
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- NCT05821569 — Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding · unknown
- NCT06310421 — Spinal Muscular Atrophy Neonatal Screening Program · recruiting
- NCT05806372 — Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy · unknown
- NCT06324578 — Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease · unknown
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 NCT03503500 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Burlo Garofolo
- Last refreshed: 22 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03503500.
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