A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies. Training in complementary feeding counselling of healthcare workers and its influence on maternal behaviours and child growth: a cluster-randomized controlled trial in Lahore, Pakistan. The first six month growth and illness of exclusively and non-exclusively breast-fed infants in Nigeria. Effects of immediate modified feeding on infantile gastroenteritis. Developmental effects of short-term supplementary feeding in nutritionally-at-risk Indonesian infants. A randomized clinical trial of home intervention for children with failure to thrive. Randomized controlled trials in pediatric surgery: could we do better? Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. Growth dynamics during the first two years of life: a prospective study in the Philippines.
to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic.
                small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed.
                a special care baby unit in a District General Hospital in the UK.
                over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14).
                the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted.
                the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis.
                if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.
                Copyright 2001 Harcourt Publishers Ltd. Malnutrition is common among children aged 6-24 months in developing countries. It increases the risk of mortality. Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children. A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children. Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries. The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques. The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance, improving feeding practices, and reducing growth faltering in children aged 6-24 months. A cluster-randomized controlled trial was carried out. The method used in this study was a replica of the method in a similar study in Pelotas, Brazil. Forty health centres were paired, and one centre of each pair was randomly allocated to the intervention group, and the other to the control group. The Integrated Management of Childhood Illness (IMCI) module-'Counsel the mother'-was used for training health workers in the health centres in the intervention group. Data from 36 paired health centres and 375 mothers and their children aged 6-24 months recruited from these health centres following consultation with health workers were included in analysis. Independent observers, masked to the intervention status, examined the performance of health workers within the first month after training. Mother-child pairs were visited at home within two weeks, 45 days, and 180 days after recruitment. Information was recorded on the feeding practices, recall of the recommendations of health workers, and sociodemographic variables at these home-visits. Weight and length of the child were measured at each contact. The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group. The mothers' recall of the recommendation of health workers and reported infant-feeding practices were also significantly better in the intervention group than in the control group, even 180 days after the recruitment consultation. Growth faltering was less in the intervention group, with the largest effect observed among children in the age-group of 12 + months. These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers. Improved feeding practices of counselled mothers can, in turn, reduce growth faltering in their children. To compare the growth and illness pattern of infants who were exclusively breast fed for six months with those of infants commenced on complementary feeding before the age of six months and ascertain reasons for the early introduction of complementary feeding.
                A comparative prospective study.
                Urban Comprehensive Health Centre (UCHC), Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife.
                Three hundred and fifty-two mothers and their normal birth weight babies, weighing 2.500kg or more, and aged less than 14 days were serially recruited into the study.
                Mean/median monthly weights in the first six months of life, history/outpatient presentation for illnesses.
                Of the 352 mother-infant pairs recruited into the study, 345 (98%) were successfully followed up for the first six months of life. At six months, 264 (76.5%) were exclusively breast-fed, 45 (13.1%) were started on complementary feeding, between the ages of four and six months while 36 (10.4%) commenced complementary feeding before the age of four months. Infants who were exclusively breast-fed for six months had median weights above the 50th percentiles of the WHO/NCHS reference that is currently used in the national "road to health" (growth monitoring) cards. Furthermore, the mean weight of these babies at age six months was above those of babies who started complementary foods before six months. They also reported fewer symptoms and had fewer illness episodes (0.1 episodes per child) compared to those who started complementary feeding before six months. Infants who commenced complementary feeding before four months reported more symptoms and had more illness episodes (1.4 episodes per child) compared to those that commenced complementary feeding between four and six months (1.2 episodes per child). Common symptoms/illnesses seen or reported during the study among the groups were fever, diarrhoea and cough. Reasons given for early introduction of complementary foods include insufficient breast milk, thirst and convenience.
                It is concluded that exclusive breast-feeding supported adequate growth during the first six months of life for most of the infants studied. Early introduction of complementary foods did not provide any advantages in terms of weight gain in our environment, it was frequently associated with illness episodes and growth faltering. Many mothers however require support, encouragement and access to health care providers to breastfeed exclusively for the first six months of life. Standard treatment of infants who are dehydrated as a result of acute gastroenteritis is to administer oral rehydration therapy (ORT). Traditionally, food has been withdrawn for 24-48 h, but there is no conclusive evidence that this is of any real benefit to the patient. Immediate modified feeding, in which an infant on ORT is not starved but administered a limited diet, may have benefits in the treatment of gastroenteritis, especially in children who are nutritionally compromised before they develop the illness.
                A pilot study was carried out to investigate the effects of giving infants suffering from acute gastroenteritis a limited modified diet in conjunction with ORT.
                Infants recruited into the study by their general practitioner or by a research doctor in the hospital casualty unit of Bristol Children's Hospital were randomly allocated to receive ORT with or without immediate modified feeding. The duration of diarrhoea, weight change, and incidence of vomiting and lactose intolerance were measured in both treatment groups, and the results were compared.
                Of the infants studied, 27 received ORT and immediate modified feeding, and 32 ORT alone. The duration of diarrhoea, and incidence of vomiting or lactose intolerance were no greater in the group receiving immediate modified feeding. Patients who received ORT and immediate modified feeding appeared to gain more weight than the infants who were starved for 24-48 h, but this difference was not statistically significant.
                Immediate modified feeding is safe and effective, and may have nutritional advantages over traditional ORT with starvation. A similar but multicentre study using unmodified diet, i.e. child's normal diet, is being carried out by a working group of The European Society of Paediatrics, Gastroenterology and Nutrition (ESPGAN). This study assessed the developmental effects of supplementary feeding over 90 consecutive days on infants aged 6-20 mo at six tea plantations in West Java, Indonesia. Every day except Sunday, the infants attended day-care centers distributed throughout the plantations. Twenty centers and 113 infants were selected; the infants in 9 centers received a dietary supplement, while the infants in 11 centers served as control subjects. Supplements were given twice a day providing, on average, 10.66 kJ (400 kcal) and 5 g protein/d. Measurements of body growth, dietary intake, and mental and motor development were made on all infants. Supplementary feeding had significant effects on weight gain and on motor development. Changes in caloric intake were independently associated with changes in weight and in motor test scores. The data suggest that the effects of the supplement may not have followed a simple mechanistic relationship from intake to weight change to motor development, but, rather, intake may have affected both growth and development domains simultaneously. To evaluate the efficacy of a home-based intervention on the growth and development of children with nonorganic failure to thrive (NOFTT).
                Randomized clinical trial.
                The NOFTT sample included 130 children (mean age, 12.7 months; SD, 6.4) recruited from urban pediatric primary care clinics serving low income families. All children were younger than 25 months with weight for age below the fifth percentile. Eligibility criteria included gestational age of at least 36 weeks, birth weight appropriate for gestational age, and no significant history of perinatal complications, congenital disorders, chronic illnesses, or developmental disabilities. Children were randomized into two groups: clinic plus home intervention (HI) (n = 64) or clinic only (n = 66). There were no group differences in children's age, gender, race, or growth parameters, or on any of the family background variables. Most children were raised by single, African-American mothers who received public assistance. Eighty-nine percent of the families (116 of 130) completed the 1-year evaluation.
                All children received services in a multidisciplinary growth and nutrition clinic. A community-based agency provided the home intervention. Families in the HI group were scheduled to receive weekly home visits for 1 year by lay home visitors, supervised by a community health nurse. The intervention provided maternal support and promoted parenting, child development, use of informal and formal resources, and parent advocacy.
                Growth was measured by standard procedures and converted to z scores for weight for height and height for age to assess wasting and stunting. Cognitive and motor development were measured with the Bayley Scales of Infant Development, and language development was measured by the Receptive/Expressive Emergent Language Scale. Both scales were administered at recruitment and at the 12-month follow-up. Parent-child interaction was measured by observing mothers and children during feeding at recruitment and at the 12-month follow-up, and the quality of the home was measured by the Home Observation Measure of the Environment 18 months after recruitment.
                Repeated-measures multivariate analyses of covariance were used to examine changes in children's growth and development and parent-child interaction. Analyses of covariance were used to examine the quality of the home. Independent variables were intervention status and age at recruitment (1.0 to 12.0 vs 12.1 to 24.9 months). Maternal education was a covariate in all analyses. When changes in developmental status and parent-child interaction were examined, weight for height and height for age at recruitment were included as covariates.
                Children's weight for age, weight for height, and height for age improved significantly during the 12-month study period, regardless of intervention status. Children in the HI group had better receptive language over time and more child-oriented home environments than children in the clinic-only group. The impact of intervention status on cognitive development varied as a function of children's ages at recruitment, with younger children showing beneficial effects of home intervention. There were no changes in motor development associated with intervention status. During the study period, children gained skills in interactive competence during feeding, and their parents became more controlling during feeding, but differences were not associated with intervention status.
                Findings support a cautious optimism regarding home intervention during the first year of life provided by trained lay home visitors. Early home intervention can promote a nurturant home environment effectively and can reduce the developmental delays often experienced by low income, urban infants with NOFTT: Subsequent investigations of home intervention should consider alternative options for toddlers with NOFTT: Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. Moderate childhood wasting is defined as having a weight-for-height Z-score (WHZ) < -2, but > or = -3. These children are typically given fortified corn/soy blended flour (CSB), but this intervention has shown limited effectiveness. Fortified spreads (FS) can be used as supplementary foods instead; they are energy-dense, lipid-based pastes with added powdered micronutrients. In this randomized clinical effectiveness trial, the recovery rates were compared among children with moderate wasting who received either milk/peanut FS, soy/peanut FS, or CSB. Children received isoenergetic quantities of food, 314 kJ x kg(-1) x d(-1), for up to 8 wk with biweekly follow-up. The primary outcome was recovery, defined as having a WHZ > -2. Time-event analysis was used to compare the recovery rate. A total of 1362 children were enrolled in the study. Children receiving soy/peanut FS had a similar recovery rate to those receiving milk/peanut FS and children in either FS group were more likely to recover than those receiving CSB (80% in both FS groups vs. 72% in the CSB group; P < 0.01). The rate of weight gain in the first 2 wk was greater among children receiving milk/peanut FS (2.6 g x kg(-1) x d(-1), n = 465) or children receiving soy/peanut FS (2.4 g x kg(-1) x d(-1), n = 450) than among children receiving CSB (2.0 g x kg(-1) x d(-1), n = 447; P < 0.05). Rates of length gain did not differ among the 3 groups. A total of 8% of children in each feeding group developed edema, indicative of severe malnutrition, while receiving supplemental feeding. We conclude that FS are superior supplementary foods to CSB for moderately wasted Malawian children. This study examines determinants of growth from birth to 24 months in a sample of approximately 3000 urban and rural Filipino children. Individual, household, and community data were collected bimonthly during the Cebu Longitudinal Health and Nutrition Survey. Separate longitudinal, multivariate models were used to identify determinants of weight in children from birth to 6 months and 6-24 months of age. Previous weight, male gender, mother's height, and season of the year showed significant positive associations with weight in all models. Full and mixed breast-feeding significantly increased weight, but the effects of breast-feeding declined as children got older. Breast-feeding had a direct growth-enhancing effect in addition to its indirect effect through the prevention of diarrheal morbidity. Detrimental effects of recent diarrheal morbidity were particularly important in the older age group, but these effects were mitigated by breast-feeding. Since infant feeding variables are included in the models, the results strongly suggest an effect of diarrheal morbidity on growth independent of its known effects on infant feeding and dietary intake. Febrile respiratory infections had important detrimental effects on weight in both age groups.
The scarcity of available studies and their heterogeneity makes it difficult to reach any firm conclusions. The review findings suggest supplementary feeding has a negligible impact on child growth; however, the pooled results should be interpreted with great caution because the studies included in the review are clinically diverse. Future studies should address issues of research design, including sample size calculation, to detect meaningful clinical effects and adequate intervention allocation concealment. In the meantime, families and children in need should be provided appropriate feeding, health care and sanitation without waiting for new RCTs to establish a research basis for feeding children.