PROmotion of Breastfeeding Intervention Trial

ISRCTN	ISRCTN37687716
DOI	https://doi.org/10.1186/ISRCTN37687716
ClinicalTrials.gov (NCT)	NCT01561612
Protocol serial number	MOP-53155
Sponsor	McGill University (Canada)
Funders	Canadian Institutes of Health Research (ref: MOP-53155), UNICEF, Thrasher Research Fund (USA), National Health Research and Development Program (NHRDP) - Health Canada (Canada), European Union (EU), National Institutes of Health (NIH) (USA)

Submission date: 25/02/2005
Registration date: 09/09/2005
Last edited: 03/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
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 childs 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 childs skin for rashes.
4. Tests the childs 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 childs 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 childrens 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 Unions project on Early Nutrition Programming: Long-term Efficacy and Safety Trials, the Thrasher Research Fund (USA), the United Nations Childrens Fund (UNICEF), and the European Regional Office of the World Health Organization (WHO).

Who is the main contact?
Prof. Michael S Kramer
Michael.Kramer@mcgill.ca

Contact information

Dr Michael S. Kramer
Scientific

The Montreal Children's Hospital
2300 Tupper Street, T-118
Montreal
H3H 1P3
Canada

Phone	+1 (0)514 4124400 ext. 22687
Email	michael.kramer@mcgill.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Breastfeeding duration and exclusivity: impact on child health and development
Study acronym	PROBIT
Study objectives	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.
Ethics approval(s)	Research Ethics Board of McGill University Health Centre, 28/11/2001 Added 02/09/2013: Research Ethics Board of McGill University Health Centre, 18/06/2012, ref: 11-190-PED
Health condition(s) or problem(s) studied	Healthy, full-term, breastfed infants
Intervention	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
Intervention type	Behavioural
Primary outcome measure(s)	One or more episodes of gastrointestinal infection in first 12 months of life.
Key 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
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	17046
Key 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
Key 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
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

Belarus
Canada

Study participating centre

The Montreal Children's Hospital

Montreal
H3H 1P3
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/10/2007		Yes	No
Results article	results	01/12/2007		Yes	No
Results article	results	01/03/2008		Yes	No
Results article	results	01/05/2008		Yes	No
Results article	results	01/12/2011		Yes	No
Results article	results	13/03/2013		Yes	No
Results article	results	01/07/2013		Yes	No
Results article	results	21/01/2014		Yes	No
Results article	results	01/07/2014		Yes	No
Results article	results	01/08/2014		Yes	No
Results article	secondary analysis results	03/07/2017		Yes	No
Results article	secondary analysis results	01/04/2018		Yes	No
Results article	secondary analysis results	01/02/2019	29/01/2020	Yes	No
Results article	secondary analysis results	01/09/2019	15/09/2020	Yes	No
Results article		23/01/2021	03/06/2021	Yes	No
Other publications	cohort profile	01/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/06/2021: Publication reference added.
15/09/2020: Publication reference added.
29/01/2020: Publication reference added.
12/04/2018: Publication reference added.
02/05/2017: Publication reference added.
02/09/2013: The overall trial start date was changed from 01/04/2002 to 01/01/1995.
09/01/2013: The following changes were made to the record:
1. The overall trial end date for this trial was changed from 01/12/2011 to 31/12/2015.
2. Belarus was added to the countries of recruitment, and Canada was removed.
25/03/2009: The overall trial end date was changed from 31/03/2008 to 01/12/2011.