Information on Breast Milk Substitutes at Hospital Discharge
Condition: Breastfeeding
Study type: Interventional

Summary: 
      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: 
      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).
    

Intervention name(s): Receiving written information on breast milk substitute
Intervention type(s): Other
Intervention description(s): Receiving written information on breast milk substitute
Allocation: Randomized
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
Keywords: breastfeeding, support, promotion