Information on Breast Milk Substitutes at Hospital Discharge

NCT03208114 | Completed

• 1 other identifier: Discharge_RCT
• Study Type: interventional
• Target: 802
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Breastfeeding

Keywords

breastfeeding, support, promotion

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding rates.

  Evaluation of exclusive breastfeeding rates according to randomization's group.

  Six months of life

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

Not receiving the written information of the name of a breast milk substitute on the infant's discharge documents

Interventions

Receiving written information on breast milk substitute OTHER

Receiving written information on breast milk substitute

Group A

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \> 2500 g
• Gestational age ≥ 37 weeks
• Singleton pregnancy
• Being exclusively breastfed from birth to discharge
• Caucasian race

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Related Publications (10)

• Bartick MC, Jegier BJ, Green BD, Schwarz EB, Reinhold AG, Stuebe AM. Disparities in Breastfeeding: Impact on Maternal and Child Health Outcomes and Costs. J Pediatr. 2017 Feb;181:49-55.e6. doi: 10.1016/j.jpeds.2016.10.028. Epub 2016 Nov 10.

  PMID: 27837954 BACKGROUND

• Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

  PMID: 26869575 BACKGROUND

• Rollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, Piwoz EG, Richter LM, Victora CG; Lancet Breastfeeding Series Group. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016 Jan 30;387(10017):491-504. doi: 10.1016/S0140-6736(15)01044-2.

  PMID: 26869576 BACKGROUND

• Mason F, Rawe K, Wright S. Superfood for Babies: How Overcoming Barriers to Breastfeeding will Save Lives. London: Save the Children; 2013.

  BACKGROUND

• Baker P, Smith J, Salmon L, Friel S, Kent G, Iellamo A, Dadhich JP, Renfrew MJ. Global trends and patterns of commercial milk-based formula sales: is an unprecedented infant and young child feeding transition underway? Public Health Nutr. 2016 Oct;19(14):2540-50. doi: 10.1017/S1368980016001117. Epub 2016 May 23.

  PMID: 27211798 BACKGROUND

• McFadden A, Mason F, Baker J, Begin F, Dykes F, Grummer-Strawn L, Kenney-Muir N, Whitford H, Zehner E, Renfrew MJ. Spotlight on infant formula: coordinated global action needed. Lancet. 2016 Jan 30;387(10017):413-5. doi: 10.1016/S0140-6736(16)00103-3. No abstract available.

  PMID: 26869552 BACKGROUND

• Piwoz EG, Huffman SL. The Impact of Marketing of Breast-Milk Substitutes on WHO-Recommended Breastfeeding Practices. Food Nutr Bull. 2015 Dec;36(4):373-86. doi: 10.1177/0379572115602174. Epub 2015 Aug 27.

  PMID: 26314734 BACKGROUND

• Sobel HL, Iellamo A, Raya RR, Padilla AA, Olive JM, Nyunt-U S. Is unimpeded marketing for breast milk substitutes responsible for the decline in breastfeeding in the Philippines? An exploratory survey and focus group analysis. Soc Sci Med. 2011 Nov;73(10):1445-8. doi: 10.1016/j.socscimed.2011.08.029. Epub 2011 Sep 17.

  PMID: 21978633 BACKGROUND

• Odom EC, Li R, Scanlon KS, Perrine CG, Grummer-Strawn L. Reasons for earlier than desired cessation of breastfeeding. Pediatrics. 2013 Mar;131(3):e726-32. doi: 10.1542/peds.2012-1295. Epub 2013 Feb 18.

  PMID: 23420922 BACKGROUND

• Mosca F, Roggero P, Garbarino F, Morniroli D, Bracco B, Morlacchi L, Mallardi D, Gianni ML, Consonni D. Determinants of breastfeeding discontinuation in an Italian cohort of mother-infant dyads in the first six months of life: a randomized controlled trial. Ital J Pediatr. 2018 Nov 6;44(1):134. doi: 10.1186/s13052-018-0572-z.

  PMID: 30400806 DERIVED

Related Links

• The link refers to a book on the global strategy for infant and young child feeding

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Fabio Mosca, Prof

  NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: January 1, 2012
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2016
• Last Updated: December 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share