Mariarosa Milinco1, Laura Travan2, Adriano Cattaneo1, Alessandra Knowles1, Maria Vittoria Sola3, Enrica Causin2, Caterina Cortivo4, Maura Degrassi4, Francesca Di Tommaso4, Giuseppa Verardi4, Laura Dipietro4, Maria Piazza4, Sabrina Scolz2, Martina Rossetto5, Luca Ronfani6. 1. Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy. 2. Neonatal Intensive Care Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy. 3. Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Trieste, Italy. 4. Obstetrics and Gynecology Department, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy. 5. Life and Health Sciences Department, University of Trieste, Trieste, Italy. 6. Clinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, Italy. luca.ronfani@burlo.trieste.it.
Abstract
BACKGROUND:Biological nurturing is a neurobehavioral approach to breastfeeding support that encourages women to breastfed in a relaxed, laidback position. This approach has the potential to reduce breast problems (e.g., sore nipples), making good latch easier and thus facilitating the initiation of exclusive breastfeeding. However, its effects have not been adequately investigated in a real-life situation. The aim of this randomized controlled trial was to assess the effectiveness of biological nurturing, compared to usual hospital practices, on the frequency of breast problems and on the prevalence of exclusive breastfeeding at discharge from the maternity ward, after 1 week, and at one and 4 months. METHODS: Open randomized parallel controlled trial carried out in a third level maternity ward (IRCCS Burlo Garofolo, Trieste, Italy) between March and December 2018. Two-hundred eight women who planned to give birth at the hospital and who expressed the intention to breastfeed were enrolled during pregnancy and randomized to receivebreastfeeding support following either the biological nurturing approach or the usual care protocol based on the WHO/UNICEF 20-h course, in use at the hospital. The primary study outcome was the incidence of breast problems during hospital stay, defined as the presence of one or more of the following outcomes, collected separately: sore nipples, cracked nipples, engorgement and mastitis. The primary analysis was performed by intention to treat. The follow up lasted 4 months. RESULTS:One hundred eighty eight out of 208 women (90.3%) were included in the analysis, 90 allocated to the biological nurturing group and 98 to the usual care group. At discharge from the maternity ward, biological nurturing significantly reduced the risk of breast problems (Relative risk [RR] 0.56, 95% Confidence Interval [CI] 0.40, 0.79), including cracked (RR 0.42, 95% CI 0.24, 0.74) and sore nipples (RR 0.59, 95% CI 0.40, 0.88). No statistically significant difference was observed for exclusive breastfeeding at discharge and up to 4 months. No adverse events occurred. CONCLUSIONS: The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems. TRIAL REGISTRATION: Clinicaltrials.gov NCT03503500. Date of First Submission: 28 March 2018.
RCT Entities:
BACKGROUND: Biological nurturing is a neurobehavioral approach to breastfeeding support that encourages women to breastfed in a relaxed, laidback position. This approach has the potential to reduce breast problems (e.g., sore nipples), making good latch easier and thus facilitating the initiation of exclusive breastfeeding. However, its effects have not been adequately investigated in a real-life situation. The aim of this randomized controlled trial was to assess the effectiveness of biological nurturing, compared to usual hospital practices, on the frequency of breast problems and on the prevalence of exclusive breastfeeding at discharge from the maternity ward, after 1 week, and at one and 4 months. METHODS: Open randomized parallel controlled trial carried out in a third level maternity ward (IRCCS Burlo Garofolo, Trieste, Italy) between March and December 2018. Two-hundred eight women who planned to give birth at the hospital and who expressed the intention to breastfeed were enrolled during pregnancy and randomized to receive breastfeeding support following either the biological nurturing approach or the usual care protocol based on the WHO/UNICEF 20-h course, in use at the hospital. The primary study outcome was the incidence of breast problems during hospital stay, defined as the presence of one or more of the following outcomes, collected separately: sore nipples, cracked nipples, engorgement and mastitis. The primary analysis was performed by intention to treat. The follow up lasted 4 months. RESULTS: One hundred eighty eight out of 208 women (90.3%) were included in the analysis, 90 allocated to the biological nurturing group and 98 to the usual care group. At discharge from the maternity ward, biological nurturing significantly reduced the risk of breast problems (Relative risk [RR] 0.56, 95% Confidence Interval [CI] 0.40, 0.79), including cracked (RR 0.42, 95% CI 0.24, 0.74) and sore nipples (RR 0.59, 95% CI 0.40, 0.88). No statistically significant difference was observed for exclusive breastfeeding at discharge and up to 4 months. No adverse events occurred. CONCLUSIONS: The biological nurturing approach applied in the real-life situation of a third level hospital was effective in preventing breast problems. TRIAL REGISTRATION: Clinicaltrials.gov NCT03503500. Date of First Submission: 28 March 2018.
Entities:
Keywords:
Biological nurturing; Breast problems; Breastfeeding; Exclusive breastfeeding; Public health