Maternal & Newborn Atlas
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PROBIT trial (Promotion of Breastfeeding Intervention Trial)

A large trial in Belarus that tested whether a programme to promote and support breastfeeding in maternity hospitals changed how long and how exclusively mothers breastfed, and how their babies fared in the first year. Hospitals, not individual mothers, were randomly assigned. The registry lists follow-up of the children at later ages.

Also called PROBIT

  • Study
  • In this atlas

Overview

Design
Cluster-randomised trial: 31 maternity hospitals and polyclinics were randomised to a breastfeeding promotion intervention modelled on the Baby-Friendly Hospital Initiative (16 sites) or to continuing usual infant feeding practices and policies (15 sites). Registry masking: none.
Phase
Not applicable
Enrolled
  • 17,046 mother-infant pairs (ClinicalTrials.gov gives no unit) (enrolled count) (Promotion of Breastfeeding Intervention Trial, retrieved )
  • 16,491 mother-infant pairs completing 12 months of follow-up (paper abstract) (unknown count) (Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus, retrieved )
Funder
Not recorded
Registry
  • NCT NCT01561612
Started
(Promotion of Breastfeeding Intervention Trial, retrieved )
Primary completion
(actual) (Promotion of Breastfeeding Intervention Trial, retrieved )
Completion
Not reported
Countries
Belarus (Promotion of Breastfeeding Intervention Trial, retrieved )
Care setting
Thirty-one maternity hospitals and polyclinics in the Republic of Belarus, as reported in the 2001 abstract. (Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT01561612 (acronym PROBIT), lead sponsor Harvard Pilgrim Health Care, collaborators include NICHD; behavioural intervention, randomised, parallel, masking none, COMPLETED. Start 1996-06, primary completion 1998-12 (actual). Registry enrolment 17046; the 2001 JAMA abstract reports 17046 mother-infant pairs from 31 maternity hospitals and polyclinics in the Republic of Belarus (16 intervention and 15 control sites) and 16491 (96.7%) completing 12 months of follow-up. The intervention was modelled on the Baby-Friendly Hospital Initiative. Registry primary outcome: gastrointestinal tract infection at 12 months of age; registry secondary outcomes include later child and maternal adiposity, asthma, cognition and others, for which no results were read. Results from the 2001 abstract are in the claims on the breastfeeding support page; no structured findings are recorded because the atlas has no outcome records for them.

Arms

  • Breastfeeding promotion and support

    Intervention Breastfeeding support and counselling

    Breastfeeding promotion according to the Baby Friendly Hospital Initiative (registry arm description).

  • Usual care

    Intervention None named

    Usual infant feeding practices and policies.

Findings

No findings are published for this study.

Record details

Record id
maternal:probit-trial
Content hash
a87b1cfac74145bd1b49d30364bfcb704664180e8c3014afdca5b9daaa9986d1