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21 March 2013
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| [ Print-friendly version ] |
| 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. Please note that 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Research Ethics Board of McGill University Health Centre approved on the 28th November 2001 |
| 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 | 01/04/2002 |
| 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 |
| 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 |
| 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 | 14/03/2013 |
| Date ISRCTN assigned | 09/09/2005 |
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