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
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