Information on Breast Milk Substitutes at Hospital Discharge

Study Overview
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Brief Summary
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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. Statistical analysis: 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).

Detailed Description
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Background: To investigators' knowledge there is paucity of data regarding the effect of the information of breast milk substitutes written on newborn's discharge medical documents on subsequent breastfeeding behavior. The aim of the study is to investigate the effect of the information of breast milk substitutes written on newborn's discharge documents on breastfeeding rates at six months of age in a cohort of mothers exclusively breastfeeding at hospital discharge. The hypothesis to be tested is that the breastfeeding rates of the mothers receiving the written information of the name of a breast milk substitute at discharge would be similar to that of the breastfeeding mothers not receiving it. Methods Ethics Statement The study was approved by the Ethics Committee of the Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, and informed written consent will be obtained from the parents. Design The investigator will conduct a prospective, controlled, single-blinded randomized trial. Breastfeeding will be promoted and supported in all mother-infant pairs throughout hospital stay. Enrollment and randomization will occur concurrently at discharge. Mother-infant pairs will be randomized either to 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). Randomization to group A or B will be performed by an independent investigator with a random permuted block size of 4. Procedures At enrollment the following maternal variables will be collected through a face to face interview: mode of delivery (vaginal delivery/caesarean section), being primiparous or multiparous, previous breastfeeding experience (yes/no; if yes how many days/months), labour duration, drugs consumption during pregnancy and/or labour, including analgesia or anesthesia, diseases arisen during pregnancy, maternal education classified as low (≤13 years) or high (>13 years), pre and post pregnancy body mass index (kg/m2), marital status, age and attitude towards smoking. Mothers will be also interviewed on pre pregnancy course attendance, intention to breastfeed and satisfaction with the breastfeeding support received during hospital stay. Timing of the first latching will be also registered. The following neonatal variables will be also collected: gestational age, gender, Apgar score values at 1 and 5 minutes, birth weight, length and head circumference. Mothers will be contacted at 7 (±3) days,1 (±7 days), 2 (±7 days), 3 (±7 days), 6 (±7 days) months after delivery by phone calls by four investigators blinded to randomization. Following a structured interview mothers will be asked whether the infant had been breastfed during the last 24 hours. Mothers will be then asked whether the infant had been fed any water and/or fruit juice and/or formula and/or semi solid and/or solid foods during the last 24 hours. Mode of feeding (exclusive breastfeeding, predominant breastfeeding, mixed breastfeeding exclusive formula feeding) will be then categorized according to the World Health Organization. If the infant will be no more breastfed, mothers will be administered a questionnaire modified after Odom et al. in order to investigate the main reasons associated with breastfeeding discontinuation. Specifically, the questionnaire focuses on the following 7 macro areas: lactation problems, milk-pumping factors, psychosocial factors, nutritional factors, life style factors, medical problems, factors related to the infant. Mothers will be asked to rate the importance of each item of the questionnaire according to a 5-point Likert scale: score 1=not at all important, score=2=not very important, score=3 moderately important, score=4 important, score=5 extremely important. Adverse events Adverse events will be assessed based on inquiries to the mothers. All adverse events will be evaluated by the investigator for severity. An adverse event will be defined as any event that will not be consistent with the information provided in the consent form or that could not reasonably be expected to accompany the natural history and progression of the subject's condition throughout the study. Adverse events will be considered serious if fatal or life-threatening, require hospitalization or surgical intervention, result in persistent or significant disability/incapacity or are considered to be medically relevant by the investigator. All other adverse events will be categorized as non-serious. Statistical analysis 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 were needed. Descriptive data will be expressed as mean±SD or number of observations (percentage). With regard to the items that are scored on a 5-point Likert scale, for the analysis, the answers will be categorized 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 will be set at a = .05 level. All statistical analyses will be performed by using SPSS (version 12, SPSS, Chicago, IL).

Official Title
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Does the Information on Breast Milk Substitutes at Hospital Discharge Affect Breastfeeding Behavior at Six Months? A Randomized Controlled Trial

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: Receiving written information on breast milk substitute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight > 2500 g Gestational age ≥ 37 weeks Singleton pregnancy Being exclusively breastfed from birth to discharge Caucasian race Exclusion Criteria: presence of congenital diseases presence of chromosomal abnormalities presence of perinatal infections presence of cardio-respiratory instability being born to mothers affected by endocrine and/or metabolic and/or gastrointestinal and/or renal diseases.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* Receiving written information on breast milk substitute<br>|
| No Intervention: Group B<br>Not receiving the written information of the name of a breast milk substitute on the infant's discharge documents | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding rates. | Evaluation of exclusive breastfeeding rates according to randomization's group. | Six months of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding, support, promotion