Breast Feeding Clinical Trial
Official title:
Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
The World Health Organization recommends exclusive breastfeeding to infants until 6 months
of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers
at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the
proportion of breastfeeding mothers in their population. Therefore, the investigators have
developed a telephonic support protocol for mothers. The intervention will be performed by
pediatric nurses in Primary Care.
The main aim of this study is to evaluate in a randomized controlled trial the effectiveness
of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to
evaluate the effectiveness of the telephonic support in any breastfeeding.
The investigators hypothesis is that this intervention will increase exclusive breastfeeding
and any breastfeeding rates.
The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants
will include breastfeeding women who have full-term healthy infants. Mothers will be
recruited upon their first arrival to Primary Care from hospital. Eligible mothers who
consent to participate will be randomized into either the intervention group or the control
group. The latter will receive standard postpartum care. The former will receive standard
postpartum care, plus a weekly telephone call during the first two months and every 2 weeks
thereafter between the second and the sixth month. The pediatric nurse responsible for
monitoring the standard care of each and every patient will be the one responsible for
contacting them via telephone. Therefore, the study is not blinded.
The evolution of exclusive breastfeeding will be compared to artificial or supplemented
feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding
supplemented with formula will also be valued. Classification into breastfeeding categories
is based on 24-hour dietary recall.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04487418 -
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
|
N/A | |
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Enrolling by invitation |
NCT02687685 -
Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
|
N/A | |
Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
Completed |
NCT03033459 -
Prenatal Lactation-Focused Motivational Interviewing
|
N/A | |
Completed |
NCT02913638 -
A Post Breastfeeding Follow-Up Study
|
N/A | |
Not yet recruiting |
NCT05846828 -
Cognitive Functions in Breastfed Preschool Children
|
||
Completed |
NCT05629403 -
Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
|
||
Completed |
NCT05944471 -
The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk
|
N/A | |
Completed |
NCT04024865 -
Domperidone and Risk of Serious Cardiac Events in Postpartum Women
|
||
Recruiting |
NCT05560750 -
Lingual Frenulum in Newborn Infants (LINNE)
|
N/A | |
Completed |
NCT03232762 -
Effects of Diet on Pregnancy Outcome and Child Obesity
|
N/A | |
Completed |
NCT01687634 -
Home Visiting for Low Income, Pregnant Women
|
N/A | |
Completed |
NCT01459991 -
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
|
N/A | |
Completed |
NCT03574766 -
Meditation for NICU Moms
|
N/A | |
Recruiting |
NCT03945474 -
Osteopathic Manipulation in Breastfed Newborns
|
N/A | |
Recruiting |
NCT06107933 -
Developmental Impacts of Microplastics Exposure in Early Life
|
||
Not yet recruiting |
NCT05059574 -
Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
|
N/A | |
Completed |
NCT04578925 -
Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
|
N/A | |
Enrolling by invitation |
NCT03337893 -
Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases
|
N/A |