Information on Breast Milk Substitutes at Hospital Discharge
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|ClinicalTrials.gov Identifier: NCT03208114|
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : December 21, 2017
Background: Although exclusively breastfeeding is recommended up to six months, current breastfeeding rates are still far from recommended targets. The investigators aim to investigate the effect of the information on breast milk substitutes at discharge on breastfeeding rates at six months of age.
Methods: A randomized controlled trial has been designed. All mother-infant pairs will be randomized to either receive the written information of the name of a breast milk substitute on the infant's discharge documents (group A) or not to receive it (group B). Mothers will receive a phone interview on mode of infants' feeding at 7 days,1, 2 , 3 and 6 months after delivery. Reasons for early discontinuation of breastfeeding according to mothers' opinion will be also collected.
Sample size: In order to detect a 10% difference in the discontinuation rate of exclusive breastfeeding at six months of age between groups, at 5% significance and 80% power, a total of 388 mother-infant pairs per group will need.
Descriptive data will be expressed as mean±SD or number of observations (percentage). With regard to the items that were scored on a 5-point Likert scale, for the analysis, the answers will categorize into two groups (not important and important).
Differences between groups in breastfeeding rates at each time point of the study will be assessed by the T-test analysis. The X2 test will be used for comparisons between discrete variables. Statistical significance is set at a = .05 level. All statistical analyses will be performed by using SPSS (version 12, SPSS, Chicago, IL).
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Other: Receiving written information on breast milk substitute||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||802 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A total mother-infant pairs enrolled will be randomized to either receive the written information of the name of a breast milk substitute on the infant's discharge documents (group A) or not to receive it (group B).|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Does the Information on Breast Milk Substitutes at Hospital Discharge Affect Breastfeeding Behavior at Six Months? A Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2012|
|Actual Primary Completion Date :||June 30, 2015|
|Actual Study Completion Date :||June 30, 2016|
Experimental: Group A
Receiving the written information of the name of a breast milk substitute on the infant's discharge documents
Other: Receiving written information on breast milk substitute
Receiving written information on breast milk substitute
No Intervention: Group B
Not receiving the written information of the name of a breast milk substitute on the infant's discharge documents
- Exclusive breastfeeding rates. [ Time Frame: Six months of life ]Evaluation of exclusive breastfeeding rates according to randomization's group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208114
|Principal Investigator:||Fabio Mosca, Prof||NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122|