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Information on Breast Milk Substitutes at Hospital Discharge

NCT03208114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2017-12-21

No results posted yet for this study

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).

Conditions

  • Breastfeeding

Interventions

OTHER

Receiving written information on breast milk substitute

Receiving written information on breast milk substitute

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Fabio Mosca, Prof · NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2015-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208114 on ClinicalTrials.gov