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PROmotion of Breastfeeding Intervention Trial
ISRCTN ISRCTN37687716
DOI 10.1186/ISRCTN37687716
ClinicalTrials.gov identifier NCT01561612
EudraCT number
Public title PROmotion of Breastfeeding Intervention Trial
Scientific title Breastfeeding duration and exclusivity: impact on child health and development
Acronym PROBIT
Serial number at source MOP-53155
Study hypothesis Current study hypothesis as of 11/03/2009:
Experimental intervention will lead to increased exclusivity and duration of breastfeeding, and hence to improved infant and child health.

Initial information at time of registration:
Experimental intervention will lead to increased exclusivity and duration of breastfeeding, and hence to reduced infection and eczema in infancy.

As of 25/03/2009, this record has been updated to include an updated anticipated end date; the initial end date at the time of registration was 31/03/2008.

As of 09/01/2013, the following changes were made to the record:
1. The anticipated end date for this trial was updated from 01/12/2011 to 31/12/2015
2. Belarus was added to the countries of recruitment, and Canada was removed

As of 02/09/2013, the anticipated start date was changed from 01/04/2002 to 01/01/1995.
Lay summary Background and study aims
The Promotion of Breastfeeding Intervention Trial (PROBIT) is a study in the Republic of Belarus involving 31 maternity hospitals and affiliated clinics across the country. The study was designed to help scientists, health care providers, and the general public understand the effects of infant feeding on child health and development.

In 1995, 16 hospitals and clinics were randomly allocated to a breastfeeding promotion intervention based on World Health Organization materials and procedures, while 15 continued breastfeeding practices in place at the time of random allocation. Mothers and babies were recruited from June 1996 to December 1997. In total, 17,046 mothers and their babies were recruited into the study. Of these, 16,492 (97%) were followed at regular intervals until the infants were 12 months of age. Detailed information was recorded at each follow-up visit about infant feeding, digestive and lung infections, and rashes.

When PROBIT children were six and a half years old, 13,889 (81%) were examined for height, weight, body fat, blood pressure, behaviour, dental health, intelligence quotient (IQ), asthma and allergy. At age 11 and a half years, 13,879 (81%) were again examined for height, weight, body fat, blood pressure, and also had blood tests to measure diabetes and heart disease risk factors. Currently we are seeing the children at age 16 years.

Who can participate?
Recruitment is complete. Mothers and their babies joined the study during their delivery hospital stay. Mothers could take part if they started breastfeeding, and they and their baby were healthy.

What does the study involve?
At the current visit, when the child is 16, the pediatrician:
1. Measures the child’s height, waist, blood pressure, weight and body fat.
2. Tests the child's vision by asking him/her to read letter charts. A small number of children are also tested using an instrument that assesses whether they need glasses.
3. Examines the child’s skin for rashes.
4. Tests the child’s lung health by asking him or her to blow into a tube three to eight times to measure the capacity of the lungs.
5. Asks the child to take a computer-administered test of brain development (including memory, ability to solve problems, attention, perception, verbal skills, information processing and motor skills).
6. Administers a questionnaire to assess other aspects of the child’s health and physical development.

What are the possible benefits and risks of participating?
The lung function assessment involves blowing hard into a tube several times. Repeated blowing may cause some people to become wheezy. The pediatrician has asthma medication on hand to relieve these symptoms if they occur. None of the other measures or tests carries any risk to the child. As a result of the examination, the pediatrician may identify previously undiagnosed eye, lung or blood pressure problems in the child, which will then be followed up appropriately.

Where is the study run from?
The study is run from the The National Research and Applied Medicine Mother and Child Centre (Minsk, Belarus), in collaboration with the School of Social and Community Medicine, University of Bristol (Bristol, UK), Departments of Pediatrics and of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine (Montreal, Canada), and Harvard Medical School and Harvard Pilgrim Health Care Institute (Boston, USA).

When is the study starting and how long is it expected to run for?
The study started in January 1995 and is expected to run until December 2015. We hope the study will extend beyond this time as we intend to look at the children’s health over many years.

Who is funding the study?
This study is supported by a grant from the Canadian Institutes of Health Research (CIHR) and the US National Institutes of Health (NIH). The study has previously been funded by the National Health Research and Development Program (NHRDP) Health Canada, European Union’s project on Early Nutrition Programming: Long-term Efficacy and Safety Trials, the Thrasher Research Fund (USA), the United Nations Children’s Fund (UNICEF), and the European Regional Office of the World Health Organization (WHO).

Who is the main contact?
Professor Michael S Kramer
Michael.Kramer@mcgill.ca
Ethics approval Research Ethics Board of McGill University Health Centre approved on 28/11/2001
Added 02/09/2013: Research Ethics Board of McGill University Health Centre approved on 18/06/2012 (Ref: 11-190-PED)
Study design Randomised controlled trial
Countries of recruitment Belarus
Disease/condition/study domain Healthy, full-term, breastfed infants
Participants - inclusion criteria 1. Birth weight equal and above 2500 g, either sex
2. Gestational age equal and above 37 weeks
3. Maternal intention to breastfeed
Participants - exclusion criteria 1. Neonatal disease or condition contraindicating breastfeeding
2. Neonatal disease or condition making breastfeeding difficult or impossible
3. Maternal psychosis
4. Maternal human immunodeficiency virus (HIV) or active tuberculosis (TB)
5. Maternal chemotherapy or radioisotopes
Anticipated start date 01/01/1995
Anticipated end date 31/12/2015
Status of trial Ongoing
Patient information material
Target number of participants 17046
Interventions Experimental group: breastfeeding promotion intervention at maternity hospitals and affiliated polyclinics
Control group: continuation of maternity hospital and polyclinic practices existing at time of
randomisation
Primary outcome measure(s) One or more episodes of gastrointestinal infection in first 12 months of life.
Secondary outcome measure(s) Current secondary outcome measures as of 09/01/2013:
1. Respiratory infections in first 12 months
2. Atopic eczema in first 12 months
3. Weight, length, and head circumference at 1, 2, 3, 6, 9, and 12 months
4. Blood pressure (BP) at age 6.5 and 9 years
5. Asthma, hay fever, atopic eczema, and allergy skin tests at age 6.5 years
6. Intelligence quotient (IQ) and behaviour at age 6.5 years
7. Oral/dental health at age 6.5 years
8. Anthropometry, lipoproteins, glucose, insulin, adiponectin, and IGF at age 11 years
9. Maternal height and weight at 6.5 and 11.5 years postpartum
10. Maternal body composition at 11.5 years postpartum
11. Maternal blood pressure at 11.5 years postpartum
12. Child metabolic syndrome at age 11.5 years
13. Eating attitudes at age 11.5 years
14. Child blood pressure at age 6.5, 11.5 and 16 years
15. Child body composition at age 11.5 and 16 years
16. Eczema, asthma, cognition, vision and lung function at age 16 years
17. Length/height and weight throughout childhood

Amended as of 11/03/2009:
8. Anthropometry, lipoproteins, glucose, insulin, adiponectin, and IGF at age 11 years

Initial information at time of registration:
1. Respiratory infections in first 12 months
2. Atopic eczema in first 12 months
3. Weight, length, and head circumference at 1, 2, 3, 6, 9, and 12 months
4. Blood pressure (BP) at age 6.5 and 9 years
5. Asthma, hay fever, atopic eczema, and allergy skin tests at age 6.5 years
6. Intelligence quotient (IQ) and behaviour at age 6.5 years
7. Oral/dental health at age 6.5 years
8. Lipids, lipoproteins, glucose, insulin, and HbA1c at age 9 years
Sources of funding 1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-53155)
2. United Nations Children's Fund (UNICEF)
3. Thrasher Research Fund (USA)
4. National Health Research and Development Program (NHRDP) - Health Canada (Canada)

Added as of 11/03/2009:
5. European Union (EU)
6. National Institutes of Health (NIH) (USA)
Trial website http://www.bristol.ac.uk/social-community-medicine/projects/probit/
Publications 1. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17855282
2. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/18065591
3. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18310164
4. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18458209
5. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21633072
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23483175
7. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23776123
8. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24300437
9. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24706729
10. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24787489
Contact name Dr  Michael S.  Kramer
  Address The Montreal Children's Hospital
2300 Tupper Street, T-118
  City/town Montreal
  Zip/Postcode H3H 1P3
  Country Canada
  Tel +1 514 4124400 ext. 22687
  Fax +1 514 4124253
  Email michael.kramer@mcgill.ca
Sponsor McGill University (Canada)
  Address 845 Sherbrooke Street West
James Administration Bldg., Suite 429
  City/town Montreal
  Zip/Postcode H3A 2T5
  Country Canada
  Sponsor website: http://www.mcgill.ca/
Date applied 25/02/2005
Last edited 06/05/2014
Date ISRCTN assigned 09/09/2005
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