Information on Breast Milk Substitutes at Hospital Discharge

December 20, 2017 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
802

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding rates.
Time Frame: Six months of life
Evaluation of exclusive breastfeeding rates according to randomization's group.
Six months of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Discharge_RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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