The effect of 4 or 6 months exclusive breastfeeding on infant breast-milk intake, growth and iron status

ISRCTN	ISRCTN41946519
DOI	https://doi.org/10.1186/ISRCTN41946519
Secondary identifying numbers	2006-P-001453/1; MGH

Submission date: 03/02/2012
Registration date: 04/04/2012
Last edited: 25/08/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The World Health organisation (WHO) recommends that all infants should be exclusively breastfed for 6 months before starting solid foods (weaning). The quality of the research on which this recommendation is based is poor, particularly for developed countries. This is an important topic because the timing of weaning might affect a number of health outcomes in the baby such as the risk of anemia (low blood cell count, low hemoglobin) and allergy. The aims of this study is to test whether mothers who are breastfeeding their healthy term baby will agree to be randomly allocated to exclusively breast-fed their baby for 4 or 6 months, and to test whether being exclusively breast-fed for either 4 or 6 months affects how much breast-milk the infant drinks at 6 months, the infant's growth pattern or the likelihood of the infant getting low iron stores and anaemia.

Who can participate?
Infants living in the areas served by 7 health clinics in Iceland can take part in the study if they are born at term (37 weeks or more), are healthy, and are exclusively breast-fed at the age of 4 months.

What does the study involve?
The study compared infants who were exclusively breast-fed for 6 months with those who were exclusively breast-fed for 4 months who then started solid foods together with continued breastfeeding.

What are the possible benefits and risks of participating?
No side effects are expected as a result of participation in the study. There are no particular benefits to the infant from taking part in the study, although mothers will get extra breastfeeding advice if they need it, and the infant will be checked for anaemia at the age of 6 months and could be treated if a problem is found.

Where is the study run from?
The study took place in 4 health centres in Iceland (2 in Reykjavik; 1 in Akranes; 1 in Hafnarfjordur)

When is the study starting and how long is it expected to run for?
The study recruited infants from November 2007 to November 2009, with 6 month follow-up finished in May 2010.

Who is funding the study?
Mead Johnson Nutritionals and Eimskip Fund of the University of Iceland.

Who is the main contact?
Dr Mary Fewtrell
m.fewtrell@ich.ucl.ac.uk

Contact information

Prof Ronald Kleinman
Scientific

Physician in Chief, MassGeneral Hospital for Children
Chair, Department of Pediatrics
Chief, Pediatric Gastrointestinal and Nutrition Unit
Massachusetts General Hospital
Charles Wilder Professor of Pediatrics
Harvard Medical School
CPZS 578
175 Cambridge Street
Boston
MA 02114
United States of America

Email	rkleinman@partners.org

Study information

Study design	Parallel-group masked randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Breastfeeding and child health: randomized controlled trial on the impact of age of introduction of weaning foods
Study acronym	ICEAGE
Study objectives	1. It is feasible to randomise mothers to exclusively breast-feed for 4 or 6 months 2. The duration of exclusive breastfeeding and the age at introduction of complementary (weaning) foods will affect infant breast-milk intake, infant growth and infant iron status at age 6 months.
Ethics approval(s)	1. Data Protection Authority and National Bioethical Committee in Iceland approved on 04/27/2007 ref: 02-164-V3-S1 2. Partners Health System IRB (US) approved on 10/25/2007, ref: 2006-P-001453/1
Health condition(s) or problem(s) studied	Healthy term infant feeding
Intervention	Exclusive breastfeeding for 6 months compared to exclsuive breastfeeding to 4 months with introduction of solid foods alongside continued breastfeeding.
Intervention type	Behavioural
Primary outcome measure	1. Feasibility 1.1 Proportion of mothers that will breastfeed exclusively for 6 months 1.2 Proportion of mothers randomized at 4 months (from those invited to participate) 2. Measurements at 6 months 2.1 Infant breast milk intake (by stable isotopes) 2.2 Infant growth 2.3 Infant iron status
Secondary outcome measures	1. Infant food intake 2. Infant body composition 3. Occurrence of upper respiratory infections and diarrheal episodes (dichotomous variables)
Overall study start date	01/11/2007
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	100 infants completing study to 6 months, from 7 healthcare centers
Key inclusion criteria	1. Healthy term infant (>37 weeks gestation) 2. No health issues affecting growth 3. No other siblings enrolled in the study 4. Exclusively breast-fed at age 4 months
Key exclusion criteria	Infant not exclusively breast-fed at age 4 months
Date of first enrolment	01/11/2007
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

Iceland
United States of America

Study participating centre

Massachusetts General Hospital

Boston
MA 02114
United States of America

Sponsor information

Mead Johnson Nutritionals (USA)
Industry

c/o - Chelsea Hunter / Tim Cooper
2400 West Lloyd Expressway B201
Evansville, In
IN47721
United States of America

Website	http://www.meadjohnson.com/
"ROR"	https://ror.org/05p4pn188

Funders

Funder type

Industry

Mead Johnson Nutrition
Private sector organisation / For-profit companies (industry)

Alternative name(s): Mead Johnson
Location: United States of America

Eimskip Fund of the University of Iceland (Iceland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Results article	results	01/05/2014		Yes	No