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Information on Breast Milk Substitutes at Hospital Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208114
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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).


Condition or disease Intervention/treatment Phase
Breastfeeding Other: Receiving written information on breast milk substitute Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 802 participants
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Exclusive breastfeeding rates. [ Time Frame: Six months of life ]
    Evaluation of exclusive breastfeeding rates according to randomization's group.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Fabio Mosca, Prof NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
Additional Information:
Publications:
Mason F, Rawe K, Wright S. Superfood for Babies: How Overcoming Barriers to Breastfeeding will Save Lives. London: Save the Children; 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03208114    
Other Study ID Numbers: Discharge_RCT
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
breastfeeding, support, promotion