Effectiveness of individualized counseling on the duration of exclusive breastfeeding: study protocol for a multicenter, randomized, parallel, and open clinical trial

Abstract Background Despite the benefits of breastfeeding, early weaning is a reality, so less than 50% of children worldwide and in Brazil are on exclusive breastfeeding in the sixth month of life. A strategy to counteract this scenario is breastfeeding counseling. This study aims to verify the effectiveness of individualized counseling by nurses trained in breastfeeding counseling, on the duration of exclusive breastfeeding, compared to standard care. Methods Multicenter, randomized, parallel, and open clinical trial, with primiparous women aged over 18 years, hospitalized in rooming-in wards at participating centers and hemodynamically stable, aware, and oriented, who had a single-fetus pregnancy and gave birth, regardless of the type of delivery, with live child, gestational age of 37 to 42 weeks and birth weight greater than 2500 g. The women will be initially approached in rooming-in wards and, upon consent to participate in the study, will be allocated through randomization by blocks composed of eight participants in two groups: intervention and control. The randomization lists will be organized by a central without involvement with the study, which will manage the allocation groups and be prepared in the Randon® program. Women allocated to the intervention group will receive breastfeeding counseling by trained nurses, and those in the control group will receive standard care at the center participating in the study. Discussion The results can contribute to breastfeeding by evidencing possible exclusivity and duration of the counseling trained nurses provide. Trial registration REBEC RBR-4w9v5rq (UTN: U1111-1284–3559) ( https://ensaiosclinicos.gov.br/rg/RBR-4w9v5rq ). Posted on March 20, 2023.