Two parallel trials to compare the effectiveness, and potential adverse side-effects, of four routinely used topical therapies to prolong breastfeeding, by either (1) preventing or (2) treating nipple pain and trauma.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Trade Name: Nystan cream Product Name: Nystan cream Pharmaceutical Form: Cream INN or Proposed INN: nystatin Other descriptive name: aluminiumhydroxide, benzyl alcohol, macrogol ether, propylene glycol, sorbitol,titanium oxide CONDITION: Nipple pain in breastfeeding women PRIMARY OUTCOME: Main Objective: Main aim: To establish in the first 14 days after birth, which of three topical treatments is most clinically and cost‐effective compared to the standard of expressed breast milk at prolonging breastfeeding by preventing or treating nipple pain and trauma.; Objectives : (1) to prolong breastfeeding to 42 days (POM); (2) to prevent/treat nipple pain up to 14 days (SOM); Primary end point(s): Any breastfeeding at six weeks of age (ascertained by telephone) Secondary Objective: INCLUSION CRITERIA: provide informed written consent; attempt at least one breastfeed; no artificial feeding prior to recruitment; aged 16+. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 4146dfd3aa5e1f06c7bcc9a600cf01617a3929b1
First added on: Aug 21, 2024