Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no, Breastfeeding Attitude, Breastfeeding Consultancy Training, Breastfeeding Duration, Breastfeeding, Exclusive, Breastfeeding Outcomes, Breastfeeding Rate, Breastfeeding Satisfaction, Breastfeeding Support System, Growth & Development
Conditions
Keywords
Breastfeeding, Infant, Human Milk, Health Education, Primary Health Care, Postpartum Period
Brief summary
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.
Interventions
BEHAVIORALbreastfeeding 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 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.
Sponsors
Fundación Pública Galega de Investigación Biomédica INIBIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mothers who express a desire to breastfeed during a follow-up consultation with the Obstetric and Gynecological Nursing or Physician 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.
Exclusion criteria
* 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. * Participate in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of exclusive breastfeeding at 6 months of age of the newborn | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Number of participants with recovery to birth weight | At 15 days and one month of age | The infant regains the weight with which they were born |
| Grams of daily weight gain | 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. |
| Age of introduction of complementary feeding | From birth to 6 months of age | Age of the infant at which complementary feeding is started in both study groups. |
| Number of Hospital admissions by the newborn | From birth to 6 months of age | Hospital admissions by the newborn in both study groups. |
| Number of emergency department visits by the newborn | From birth to 6 months of age | number and reason for emergency department visits by the newborn in both study groups. |
| Number of visits by the pediatric nurse specialist | Until completion of the study (6 months after birth) | Number and reason for visits by the pediatric nurse specialist in both study groups. |
| Number of visits to the specialist nurse in Obstetric-Gynecological Nursing | Until completion of the study (6 months after birth) | Number of visits to the specialist nurse in Obstetric-Gynecological Nursing |
| Days after birth of cessation of breastfeeding | Until completion of the study (6 months after birth) | Days of the infant's life when the last breastfeeding is administered |
| Score on the validated scale of impact of support networks in breastfeeding | 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. |
| Score of Maternal Breastfeeding Evaluation Scale (MBFES-E) | 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. |
Countries
Spain
Contacts
CONTACTYolanda suarez Sánchez Suárez
CONTACTCarmen Neri Fernández Pombo, PhD
PRINCIPAL_INVESTIGATORYolanda Sánchez Suárez
Servicio Gallego de Salud
PRINCIPAL_INVESTIGATORCarmen Neri Fernández Pombo, PhD
Servicio Gallego de Salud. Instituto de Investigación Biomédica de A Coruña.
STUDY_DIRECTORJavier Muñíz García, PhD
Universidade de A Coruña
Outcome results
None listed