Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Rate of exclusive breastfeeding at 6 months of age of the newborn
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Conventional care
Conventional care within the Child Health Program (SERGAS) The health program includes 5 appointments with the Pediatric Specialist doctor and the Pediatric Specialist nurse in the first 6 months of life. These appointments will take place at 7-15 days, at 1 month, at 2 months, at 4 months, and at 6 months of age.
breastfeeding counseling
干预措施: breastfeeding counseling (Behavioral)
结局指标
主要结局
Rate of exclusive breastfeeding at 6 months of age of the newborn
时间窗: From birth up to 6 months of the infant's life
The practice of feeding the infant exclusively with breast milk from 0 to 5 months (without giving any other food or drink, not even water). Nursing by a wet nurse, feeding with expressed breast milk, and feeding with breast milk from donors are also considered breastfeeding.
次要结局
- Number of participants with exclusive breastfeeding at 15 days, one month, and three months of the newborn's life.(At 15 days, one month, and three months of the newborn's life.)
- Number of participants with recovery to birth weight(At 15 days and one month of age)
- Number of Hospital admissions by the newborn(From birth to 6 months of age)
- Number of emergency department visits by the newborn(From birth to 6 months of age)
- Number of visits to the specialist nurse in Obstetric-Gynecological Nursing(Until completion of the study (6 months after birth))
- Days after birth of cessation of breastfeeding(Until completion of the study (6 months after birth))
- Grams of daily weight gain(At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life)
- Age of introduction of complementary feeding(From birth to 6 months of age)
- Number of visits by the pediatric nurse specialist(Until completion of the study (6 months after birth))
- Reasons reasons given by the mother in an interview for breastfeeding abandonment(6 months after birth or when the mother abandons the study)
- Score on the validated scale of impact of support networks in breastfeeding(6 months after birth or when the mother abandons the study)
- Score of Maternal Breastfeeding Evaluation Scale (MBFES-E)(6 months after birth or when the mother abandons the study)
研究者
Yolanda Sánchez Suárez
Nurse specialist in Pediatric Nursing
Fundacion Profesor Novoa Santos