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Background: Immediate and exclusive initiation of breastfeeding after delivery has been associated with better neonatal survival and child health and are recommended by the WHO. We report its impact on early infant feeding practices from the PROMISE-EBF trial. Methods: PROMISE-EBF was a cluster randomised behaviour change intervention trial of exclusive breastfeeding (EBF) promotion by peer counsellors in Burkina Faso, Uganda and South Africa implemented during 2006-2008 among 2579 mother-infant pairs. Counselling started in the last pregnancy trimester and mothers were offered at least five postnatal visits. Early infant feeding practices: use of prelacteal feeds (any foods or drinks other than breast milk given within the first 3 days), expressing and discarding colostrum, and timing of initiation of breastfeeding are presented by trial arm in each country. Prevalence ratios (PR) with 95% confidence intervals (95%CI) are given. Results: The proportion of women who gave prelacteal feeds in the intervention and control arms were, respectively: 11% and 36%, PR 0.3 (95% CI 0.2, 0.6) in Burkina Faso, 13% and 44%, PR 0.3 (95% CI 0.2, 0.5) in Uganda and 30% and 33%, PR 0.9 (95% CI 0.6, 1.3) in South Africa. While the majority gave colostrum, the proportion of those who expressed and discarded it in the intervention and control arms were: 8% and 12%, PR 0.7 (95% CI 0.3, 1.6) in Burkina Faso, 3% and 10%, PR 0.3 (95% CI 0.1, 0.6) in Uganda and 17% and 16%, PR 1.1 (95% CI 0.6, 2.1) in South Africa. Only a minority in Burkina Faso (< 4%) and roughly half in South Africa initiated breastfeeding within the first hour with no large or statistically significant differences between the trial arms, whilst in Uganda the proportion of early initiation of breastfeeding in the intervention and control arms were: 55% and 41%, PR 0.8 (95% CI 0.7, 0.9). Conclusions: The PROMISE-EBF trial showed that the intervention led to less prelacteal feeding in Burkina Faso and Uganda. More children received colostrum and started breastfeeding early in the intervention arm in Uganda. Late breastfeeding initiation continues to be a challenge. No clear behaviour change was seen in South Africa.
The design and undertaking of the trial has been described previously [12]. Briefly, the study was conducted in three countries: 1) Banfora in south-west Burkina Faso, a rural area dominated by subsistence farming; 2) in eastern Uganda, the sites comprised rural Bungokho where both subsistence farming and petty trading are common, and urban Mbale Municipality characterised by informal settlements and small industries; and 3) in South Africa, three geographically separate sites included Paarl, a commercial farming area in the Western Cape Province, peri-urban Umlazi, and the rural Rietvlei in KwaZulu-Natal. Infant mortality rates (IMRs) at the time of the study were 92/1,000 in Burkina Faso and 85/1,000 in Uganda. In South Africa the IMRs were 40/1,000 in Paarl, 60/1,000 in Umlazi and 99/1,000 in Rietvlei [13]. Furthermore, at the time of the study HIV-prevalence and also access to testing and prevention-of-mother-to-child transmission of HIV (PMTCT) services varied considerably between the three countries: In Burkina Faso and Uganda the estimated prevalence of maternal HIV was 6% while it was 29% in South Africa [14, 15]. Cluster-randomisation was 1:1, stratified by country and sites. In Burkina Faso, randomisation was not stratified as the clusters were considered homogeneous at baseline with regard to sociodemographic characteristics; in Uganda, it was stratified according to urban and rural location, and in South Africa according to the three sites which were geographically different. A cluster comprised 1-2 villages or communities with an average of 1000 inhabitants (~35 infants born per year, i.e. a birth rate of 3.5%). Clusters were selected in close collaboration with community leaders. Care was taken to allow for ‘corridors’ between selected clusters to avoid potential contamination across clusters. In each site, clusters were randomised to either the intervention (EBF peer-counselling) or the control arm, where EBF was not promoted by our research team. In South Africa, peer support for families to obtain birth certificates and social welfare grants by separate counsellors was provided in the control clusters. The peer counsellors supporting and promoting EBF for six months were from the same communities as the mothers. They were trained in a one week course by the national research teams with a curriculum from the WHO courses ‘Breastfeeding Counselling: a Training Course’ [16] and ‘HIV & Infant Feeding Counselling: a Training Course’ [17] adapted for the sites. This curriculum came with basic illustrations that were used to ease discussion of latching techniques and positioning of the baby and mother. The curriculum was thoroughly pretested [18] and the research team addressed in detail the pre- and post- training knowledge among the peer counsellors [19]. The WHO curriculum was supplemented with basic training because it focuses only on breastfeeding excluding several aspects such as the need for community acceptance and permission from the husbands. To meet these needs, the curriculum was adapted to the local context, particularly paying attention to commonly used traditional and cultural liquids given to newborns. The peer counsellors’ knowledge was assessed and found satisfactory before implementation and they were followed up at least monthly during the intervention period. The sessions with the mother included theoretical knowledge on exclusive breastfeeding and the peers also got knowledge to guide mothers having common difficulties like engorgement and sore nipples; and to recognise more serious problems like mastitis and abscesses. The sessions with the mothers were mostly interactive processes and were scheduled to fit the mother’s programme in her home. All mothers were offered at least five visits, one of which occurred towards the end of pregnancy. Roughly speaking they lasted from 15 minutes to an hour, but those data are not valid for quantitative analysis. The intervention is described previously [12, 19–21]. Pregnant women residing in the clusters, intending to breastfeed and with no intention to move were recruited into the study. HIV status was not a recruitment consideration. In Uganda eligible women were identified by recruiters in the study areas and thereafter approached for data collection. In Burkina Faso and South Africa, a random sample of mothers in the intervention clusters were approached for data collection as the number of women receiving the intervention in the clusters exceeded the sample size requirements. Exclusion criteria for data collection were severe psychological illness which could interfere with consent or trial collaboration, and having given birth more than 1 week before the first data collection contact. The mother-infant pairs were assessed three weeks after delivery and if the child had any severe malformation that could interfere with breastfeeding they were excluded from data collection. Sample size calculation was done for EBF and diarrhoea prevalence at 12 weeks [12], not for the primary outcome of this paper. A full trial profile by arm and country is already published [12, 22]. The analysis included 2,579 singleton live children. A post hoc power calculation found very high power (0.8-1) for the detected differences in prelacteal feeding, early initiation of breastfeeding and not giving colostrum (Additional file 1). Data collection was done from 2006 to 2008 by trained interviewers in a series of five interviews: a recruitment visit late in pregnancy, and visits at 3 (timely visit range: 1.5–4.5) weeks; 6 (4.5–9) weeks; 12 (9–18) weeks; and 24 (18–28) weeks after birth. The first interview focused mainly on sociodemographic and socioeconomic characteristics. The follow-up visits addressed feeding patterns, infant illness, and anthropometric measurements. Early infant feeding practices were assessed in the first interview after birth. If the respondent was not available at that interview, the next two interviews provided an opportunity to answer the early infant feeding questions. Structured questionnaires were developed and adapted from the literature [23, 24] as well as from prior work in the participating countries [25–27]. Prelacteal feeding was defined as any non-breast milk feeds given within the first three days after birth. The women were asked if the baby was given 1) any mouthfuls to drink other than breast milk within the first three days after birth, and thereafter 2) any drops of something to taste. The latter was intended to capture religious or traditional practices. If they answered ‘yes’ to prelacteal feeds they were asked to answer yes or no to a predefined food list of 16 items that were identified through formative research [25]. Regarding giving or not giving colostrum the women were asked if they gave the first milk to the baby or expressed and discarded it. Initiation of breastfeeding was determined by the timing of the first breastfeed. The following cumulative categories were created based on categorical data collection: Within the first hour; within 12 hours; within 24 hours and after. Factors associated with the non-recommended early feeding practices prelacteal feeds and late (after 12 hours) initiation of breastfeeding were studied. The factors of interest related to the mother were: maternal body mass index, kg/m2 (BMI) at six weeks; place of delivery, ‘facility delivery’ contrasting ‘home delivery’; type of delivery, ‘normal vaginal’ contrasting ‘Caesarean-section, breech or other complications’; parity; socioeconomy where the two top quintiles contrasted the 3 bottom quintiles, the quintiles were derived from multiple correspondence analysis [12, 28]; education given as years of schooling; antenatal care attendance; and the intervention package. Factors related to the child were body size and gender. The PROMISE-EBF trial did not capture birth weight, however, we asked for birth weight at the 3-week interview. In Burkina Faso, 98% could not report any birth weight, contrasting 65% in Uganda and 8% in South Africa. We therefore had limited and unreliable birth-weight data. As a proxy for size at birth, we used the 3-week anthropometric data, weight-for-length, length-for-age and weigh-for-age z-scores according to the WHO Child Growth standards [29], acknowledging the limitation that early infant feeding practices may have influenced the anthropometric status of the child at 3 weeks. Descriptive statistics included means with 95% confidence intervals (CI), medians and ranges for continuous variables and proportions for categorical variables. For the categorical data, generalised linear models of the binomial family with a log link were used to calculate prevalence ratios (PR). This was done a) by trial allocation and b) according to a cohort design where statistically significant factors associated with the outcome at the p <0.05 level, socio-economic and the trial allocation went into the multi-variable models. Analysis was done by country and all presented data were adjusted for the design effect by having randomized clusters rather than individuals. The data were analysed using STATA 11 SE (Stata Corp LP, College Station, TX, USA). Approval for the trial (ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT00397150","term_id":"NCT00397150"}}NCT00397150) was obtained from the following bodies: 1) Burkina Faso: Institutional Review board of Centre Muraz (No 013/2005/CE-CM) and the Ministry of Health at national and regional level; 2) Uganda: Makerere University Faculty of Medicine Research and Ethics Committee, and the Uganda National Council for Science and Technology; 3) South Africa: Ethics Committee of the Medical Research Council South Africa; and 4) Norway: Regional Committees for Medical and Health Research Ethics (REK VEST), 8 Sept 2005, issue number 05/8197. Women provided verbal informed consent for participation in the peer-counselling programme, which was regarded as a service. Written informed consent for participation in the study was signed or thumb-printed by each respondent.
