NCT Number: NCT07309510
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
A Coruña, Galicia, Spain
Julia Varas Merino
SUB_INVESTIGATOR
Tania Súarez Lavandeira
SUB_INVESTIGATOR
Yolanda Sánchez Suárez
CONTACT
Yolanda Sánchez Suárez
PRINCIPAL_INVESTIGATOR
Úrsula Nieto Caamaño
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 related to breastfeeding, and the breastfeeding clinical record form from the World Health Organization (WHO). Training will be provided to the mother and family on pre-selected breastfeeding topics. Mothers will be able to contact the IP nurse by phone daily on demand from 10 a.m. to 3 p.m.
Time frame: 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.
Time frame: At 15 days, one month, and three months of the newborn's life.
Defined as the practice of feeding the infant exclusively with breast milk (without giving any other food or drink, not even water). Breastfeeding by a wet nurse, feeding with expressed breast milk, and feeding with donor breast milk are also considered breastfeeding.
Time frame: At 15 days and one month of age
The infant regains the weight with which they were born
Time frame: At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life
Grams of weight gained per day since the previous weight check.
Time frame: From birth to 6 months of age
Age of the infant at which complementary feeding is started in both study groups.
Time frame: From birth to 6 months of age
Hospital admissions by the newborn in both study groups.
Time frame: From birth to 6 months of age
number and reason for emergency department visits by the newborn in both study groups.
Time frame: Until completion of the study (6 months after birth)
Number and reason for visits by the pediatric nurse specialist in both study groups.
Time frame: Until completion of the study (6 months after birth)
Number of visits to the specialist nurse in Obstetric-Gynecological Nursing
Time frame: Until completion of the study (6 months after birth)
Days of the infant's life when the last breastfeeding is administered
Time frame: 6 months after birth or when the mother abandons the study
Reasons for breastfeeding discontinuation among the study groups.
Time frame: 6 months after birth or when the mother abandons the study
Score on the validated scale of impact of support networks in breastfeeding Validated scale of the impact of support networks on breastfeeding. Composed of 12 items, self-administered. Mothers must indicate their level of agreement or disagreement with the statements using a 5-point Likert scale. The maximum score is 60 points and the minimum is 12 points. A higher score indicates a greater degree of satisfaction or perceived quality among users of breastfeeding support services.
Time frame: 6 months after birth or when the mother abandons the study
Score on the Spanish version of the Maternal Breastfeeding Evaluation Scale (MBFES-E). A 5-point Likert-type scale is used in which the participant rates their level of agreement with the item statement (1: strongly disagree to 5: strongly agree). The final score on the scale will range from 30 to 150 and is interpreted such that a higher score indicates greater satisfaction with the breastfeeding experience.
Contact information is provided by the study sponsor or research team.
Carmen Neri Fernández Pombo, PhD
CONTACT
Yolanda suarez Sánchez Suárez
CONTACT
Fundación Pública Galega de Investigación Biomédica INIBIC
Other
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center in A Coruña.Randomized Controlled Clinical Trial
Acronym: ALM-AP
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