Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center

Официальное название

Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial

Обзор

Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother. Many breasfeeding are abandoned early due difficulties experienced after dischargue and after returning to work. Development specific early breastfeeding support programs in the community is necessary to avoid unwanted abandonment. Objective: To analyse the differences in BF rates at six month of birth in healthy full-term newborns between the study groups. Methodology: Pilot study of a randomised clinical trial carried out in a Paediatric Nursing clinic at the Ventorrillo Health Centre in A Coruña. The study population will be mothers of healthy full-term newborns who wish to give BF at the time of delivery and whose reference health centre is the one of the study. The mother- newborn dyads in the control group (CG) will receive the usual care described in the child health Program of the Galician Health Service, and the dyads included in the intervention group (IG) will also receive specific advice on breastfeeding during the first 6 months of life. A study sample of 80 participants is estimated for each group. The study will be approved by the Research Ethics Committee of A Coruña-Ferrol. The variables under study will be collected in a data collection notebook for later statistical analysis. A significant value of p \< 0.05 being considered.

Вмешательства

• Поведенческое breastfeeding counseling
  The intervention group will receive, in addition to the indicated conventional care, 4 scheduled breastfeeding counseling appointments, the first of which will take place within the first 72 hours after hospital discharge following birth. As part of the breastfeeding counseling, the Latch scale will be used to observe and assess breastfeeding sessions, the breastfeeding self-efficacy scale-short (BSES-SF) to evaluate breastfeeding self-efficacy, the Visual Analogue Scale (VAS) to evaluate pain r

Первичные конечные точки

• Rate of exclusive breastfeeding at 6 months of age of the newborn [Срок оценки: From birth up to 6 months of the infant's life]

Вторичные конечные точки (12)

• Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life. [Срок оценки: At 15 days, one month, and three months of the newborn's life.]
• Number of participants with recovery to birth weight [Срок оценки: At 15 days and one month of age]
• Grams of daily weight gain [Срок оценки: At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life]
• Age of introduction of complementary feeding [Срок оценки: From birth to 6 months of age]
• Number of Hospital admissions by the newborn [Срок оценки: From birth to 6 months of age]
• Number of emergency department visits by the newborn [Срок оценки: From birth to 6 months of age]
• Number of visits by the pediatric nurse specialist [Срок оценки: Until completion of the study (6 months after birth)]
• Number of visits to the specialist nurse in Obstetric-Gynecological Nursing [Срок оценки: Until completion of the study (6 months after birth)]
• Days after birth of cessation of breastfeeding [Срок оценки: Until completion of the study (6 months after birth)]
• Reasons reasons given by the mother in an interview for breastfeeding abandonment [Срок оценки: 6 months after birth or when the mother abandons the study]
• Score on the validated scale of impact of support networks in breastfeeding [Срок оценки: 6 months after birth or when the mother abandons the study]
• Score of Maternal Breastfeeding Evaluation Scale (MBFES-E) [Срок оценки: 6 months after birth or when the mother abandons the study]

Критерии участия

Критерии включения

• Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing specialist at 36 weeks of gestation.
• Mothers who plan to give birth at HMI of CHUAC, referred from the C.S. Ventorrillo.
• Women who are fluent in Spanish or Galician.

Критерии исключения

• Maternal age under 18 years - Maternal use of drugs or medication that prevent breastfeeding .
• Maternal infection with HIV or Human T-cell Leukemia Virus.
• Mothers of newborns with cow's milk protein allergy, galactosemia, or congenital primary lactase deficiency.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Centro de Salud de O Ventorrillo — A Coruña

Идентификаторы

NCT: NCT07309510 · 2025/235 · 2025/235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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