An interventional study of breastfeeding counseling in Growth & Development, Breastfeeding Satisfaction and Breastfeeding Consultancy Training, sponsored by Fundación Pública Galega de Investigación Biomédica INIBIC. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Fundación Pública Galega de Investigación Biomédica INIBIC · Not applicable, Interventional, and Supportive care
Among 35 studies in Breast Feeding with a site in Spain — 6 open to participants now, 9 under way, none of them phase 3. Breast Feeding · Spain.
Among the 35 studies in Breast Feeding with a site in Spain, this one is the 14th largest by planned enrollment of the 25 interventional ones, is one of 4 that started in 2026, is one of 20 with no phase, and was the 30th registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →6 of the 35 studies in Breast Feeding with a site in Spain are open now, in 1 country. Each count lists the studies.
Of the 126 Breast Feeding studies recruiting now, 66 (52%) set no upper age limit and 58 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2026.
Median enrollment 200 across the 25 interventional studies, 150 across the 10 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
6 of 35 have an industry lead sponsor. The 10 most frequent:
Fundación Pública Galega de Investigación Biomédica INIBIC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Fundación Pública Galega de Investigación Biomédica INIBIC has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
3 of the studies in Breast Feeding with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07508917Fundació Sant Joan de DéuEffects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation | 2026-11-30 |
| NCT07635771Institut Investigacio Sanitaria Pere VirgiliDevelopment of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success. | 2027-06 |
| NCT07309510Fundación Pública Galega de Investigación Biomédica INIBICEffectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center | 2027-08 |
Among the 35 studies in Breast Feeding with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: 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 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.
Rate of exclusive breastfeeding at 6 months of age of the newborn
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: From birth up to 6 months of the infant's life
Number of participants with exclusive breastfeeding 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, one month, and three months of the newborn's life.
Number of participants with recovery to birth weight
The infant regains the weight with which they were born
Time frame: At 15 days and one month of age
Grams of daily weight gain
Grams of weight gained per day since the previous weight check.
Time frame: At 15 days, 1 month, 2 months, 4 months and 6 months of the infant's life
Age of introduction of complementary feeding
Age of the infant at which complementary feeding is started in both study groups.
Time frame: From birth to 6 months of age
Number of Hospital admissions by the newborn
Hospital admissions by the newborn in both study groups.
Time frame: From birth to 6 months of age
Number of emergency department visits by the newborn
number and reason for emergency department visits by the newborn in both study groups.
Time frame: From birth to 6 months of age
Number of visits by the pediatric nurse specialist
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
Number of visits to the specialist nurse in Obstetric-Gynecological Nursing
Time frame: Until completion of the study (6 months after birth)
Days after birth of cessation of breastfeeding
Days of the infant's life when the last breastfeeding is administered
Time frame: Until completion of the study (6 months after birth)
Score on the validated scale of impact of support networks in breastfeeding
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 of Maternal Breastfeeding Evaluation Scale (MBFES-E)
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.
Time frame: 6 months after birth or when the mother abandons the study
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Aug 2027, 18 months after the start.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 18 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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Fundación Pública Galega de Investigación Biomédica INIBIC