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author:("goto, Norman")
1.  Meat consumption is associated with less stunting among toddlers in four diverse low-income settings 
Food and nutrition bulletin  2011;32(3):185-191.
Background
Early growth faltering is common but is difficult to reverse after the first 2 years of life.
Objective
To describe feeding practices and growth in infants and young children in diverse low-income settings prior to undertaking a complementary feeding trial.
Methods
This cross-sectional study was conducted through the Global Network for Women’s and Children’s Health Research in Guatemala, Democratic Republic of Congo, Zambia, and Pakistan. Feeding questionnaires were administered to convenience samples of mothers of 5- to 9-month old infants and 12- to 24-month-old toddlers. After standardized training, anthropometric measurements were obtained from the toddlers. Following the 2006 World Health Organization Growth Standards, stunting was defined as length-for-age < −2SD, and wasting as weight-for-length < −2SD. Logistic regression was applied to evaluate relationships between stunting and wasting and consumption of meat (including chicken and liver and not including fish).
Results
Data were obtained from 1,500 infants with a mean (± SD) age of 6.9 ± 1.4 months and 1,658 toddlers with a mean age of 17.2 ± 3.5 months. The majority of the subjects in both age groups were breastfed. Less than 25% of the infants received meat regularly, whereas 62% of toddlers consumed these foods regularly, although the rates varied widely among sites. Stunting rate ranged from 44% to 66% among sites; wasting prevalence was less than 10% at all sites. After controlling for covariates, consumption of meat was associated with a reduced likelihood of stunting (OR = 0.64; 95% CI, 0.46 to 0.90).
Conclusions
The strikingly high stunting rates in these toddlers and the protective effect of meat consumption against stunting emphasize the need for interventions to improve complementary feeding practices, beginning in infancy.
PMCID: PMC3918945  PMID: 22073791
Complementary feeding; infant growth; infant nutrition; stunting
2.  Tobacco Use and Secondhand Smoke Exposure During Pregnancy in Two African Countries: Zambia and the Democratic Republic of the Congo 
Acta obstetricia et gynecologica Scandinavica  2010;89(4):10.3109/00016341003605693.
Objective
To study pregnant women’s knowledge, attitudes and behaviors towards tobacco use and secondhand smoke (SHS) exposure, and exposure to advertising for and against tobacco products in Zambia and the Democratic Republic of the Congo (DRC).
Design
Prospective cross-sectional survey between November 2004 and September 2005.
Setting
Antenatal care clinics in Lusaka, Zambia and Kinshasa, DRC.
Population
Pregnant women in Zambia (909) and the DRC (847).
Methods
Research staff administered a structured questionnaire to pregnant women attending antenatal care clinics.
Main Outcome Measures
Pregnant women’s use of tobacco, exposure to SHS, knowledge of the harms of tobacco, and exposure to advertising for and against tobacco products.
Results
Only about 10% of pregnant women reported having ever tried cigarettes (6.6% Zambia; 14.1% DRC). However, in the DRC, 41.8% of pregnant women had ever tried other forms of tobacco, primarily snuff. About 10% of pregnant women and young children were frequently or always exposed to SHS. Pregnant women’s knowledge of the hazards of smoking and SHS exposure was extremely limited. About 13% of pregnant women had seen or heard advertising for tobacco products in the last 30 days.
Conclusions
Tobacco use and SHS exposure pose serious threats to the health of women, infants, and children. In many African countries, maternal and infant health outcomes are often poor and will likely worsen if maternal tobacco use increases. Our findings suggest that a “window of opportunity” exists to prevent increased tobacco use and SHS exposure of pregnant women in Zambia and the DRC.
doi:10.3109/00016341003605693
PMCID: PMC3875167  PMID: 20230310
3.  EVALUATION OF MEAT AS A FIRST COMPLEMENTARY FOOD FOR BREASTFED INFANTS: IMPACT ON IRON INTAKE & GROWTH 
Nutrition reviews  2011;69(0 1):10.1111/j.1753-4887.2011.00434.x.
The rationale is considered for promoting the availability of local, affordable, non-fortified food sources of bioavailable iron in developing countries. Intakes of iron from the regular consumption of meat from the age of six months are evaluated with respect to physiological requirements. The paper includes a description of two major randomized controlled trials of meat as a first and regular complementary food that are currently in progress. These trials involve poor communities in Guatemala, Pakistan, Zambia, Democratic Republic of the Congo and China.
doi:10.1111/j.1753-4887.2011.00434.x
PMCID: PMC3875190  PMID: 22043884
iron; meat; complementary feeding
4.  Application of Neurodevelopmental Screening to a Sample of South American Infants: The Bayley Infant Neurodevelopmental Screener (BINS) 
Infant behavior & development  2012;35(2):280-294.
Objective
To evaluate the utility of the Bayley Infant Neurodevelopmental Screener (BINS), standardized in the US, for South American infants, 3 to 24 months of age.
Method
Thirty-five physicians administered the BINS to 2,471 South American infants recruited during routine well-child visits, 578 (23%) from Brazil and 1,893 (77%) from six other South American countries. The BINS was translated into Spanish and Portuguese and participating physicians were trained to administer the BINS. Physician inter-rater agreement with training tapes was 84.4%; test-retest reliability for age item sets ranged from 0.80 to 0.93 (Pearson’s r). Infants were classified into being at low, moderate, or high risk for developmental delay or neurological impairment based on their total BINS score. The sample was stratified by infant’s age, sex and language (Spanish and Portuguese). The BINS scores were compared to the scores of the US infant sample used to standardize the BINS.
Results
Female infants performed higher than male at 16 to 20 months and 21 to 24 months; male infant scores were more variable at 5 to 6 months. Scores on only two items were significantly different between Spanish and Portuguese speaking participants. South American scores were typically significantly higher than the US sample, and a lower proportion of infants were classified as being at high risk in the South American sample than in the US standardization sample.
Conclusion
Overall, the results of this study indicate that the BINS is feasible and appropriate for neurodevelopmental screening in South America. Further studies are needed to confirm the BINS utility in South America, including its use with a clinical sample.
doi:10.1016/j.infbeh.2011.12.003
PMCID: PMC3306498  PMID: 22244313
Developmental screening; infants; South America; Bayley Infant Neurodevelopmental Screener
5.  Infant Stunting Is Associated With Short Maternal Stature 
The objectives were to determine the range of maternal height associated with growth velocity of older infants and the magnitude of this association in an indigent population. Maternal height and infant length-for-age z scores (LAZ) were positively correlated at both 6 (n=412, r=0.324) and 12 (n=388, r=0.335) months (P<0.0001) and for maternal heights from 131 to 164 cm. Maternal height is independently associated with infant LAZ and stunting (LAZ <−2) at both 6 and 12 months (P<0.001) and with linear growth velocity from 6 to 12 months (P=0.0023).
doi:10.1097/MPG.0b013e3182331748
PMCID: PMC3607506  PMID: 21866055
infant growth; maternal height; stunting
6.  High Dosage Folic Acid Supplementation, Oral Cleft Recurrence and Fetal Growth 
Objectives: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. Patients and Methods: The study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid supplementation groups: 0.4 and 4 mg per day before pregnancy and throughout the first trimester. The infant outcome data were based on 234 live births. In addition to oral cleft recurrence, several secondary outcomes were compared between the two folic acid groups. Cleft recurrence rates were also compared to historic recurrence rates. Results: The oral cleft recurrence rates were 2.9% and 2.5% in the 0.4 and 4 mg groups, respectively. The recurrence rates in the two folic acid groups both separately and combined were significantly different from the 6.3% historic recurrence rate post the folic acid fortification program for this population (p = 0.0009 when combining the two folic acid groups). The rate of cleft lip with palate recurrence was 2.9% in the 0.4 mg group and 0.8% in the 4 mg group. There were no elevated fetal growth complications in the 4 mg group compared to the 0.4 mg group. Conclusions: The study is the first double-blinded randomized clinical trial (RCT) to study the effect of high dosage folic acid supplementation on isolated oral cleft recurrence. The recurrence rates were similar between the two folic acid groups. However, the results are suggestive of a decrease in oral cleft recurrence compared to the historic recurrence rate. A RCT is still needed to identify the effect of folic acid on oral cleft recurrence given these suggestive results and the supportive results from previous interventional and observational studies, and the study offers suggestions for such future studies. The results also suggest that high dosage folic acid does not compromise fetal growth.
doi:10.3390/ijerph10020590
PMCID: PMC3635165  PMID: 23380913
oral clefts; cleft lip; cleft palate; birth defects; folic acid; vitamins; prevention; pregnancy; nutrition; Brazil; NCT00397917
7.  Oral cleft prevention program (OCPP) 
BMC Pediatrics  2012;12:184.
Background
Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted.
Methods/design
This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with nonsyndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4mg, 0.4 mg) to that of a historical control group.
The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings.
Discussion
The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women.
ClinicalTrials.gov Identifier
NCT00397917
doi:10.1186/1471-2431-12-184
PMCID: PMC3532199  PMID: 23181832
Oral clefts; Cleft lip; Cleft palate; Craniofacial anomalies; Congenital anomalies; Birth defects; Folic acid; Vitamins; Prevention
8.  The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts 
BMC Pediatrics  2011;11:121.
Background
Cleft lip and/or palate (CL/P) increase mortality and morbidity risks for affected infants especially in less developed countries. This study aimed at assessing the effects of systematic pediatric care on neonatal mortality and hospitalizations of infants with cleft lip and/or palate (CL/P) in South America.
Methods
The intervention group included live-born infants with isolated or associated CL/P in 47 hospitals between 2003 and 2005. The control group included live-born infants with CL/P between 2001 and 2002 in the same hospitals. The intervention group received systematic pediatric care between the 7th and 28th day of life. The primary outcomes were mortality between the 7th and 28th day of life and hospitalization days in this period among survivors adjusted for relevant baseline covariates.
Results
There were no significant mortality differences between the intervention and control groups. However, surviving infants with associated CL/P in the intervention group had fewer hospitalization days by about six days compared to the associated control group.
Conclusions
Early systematic pediatric care may significantly reduce neonatal hospitalizations of infants with CL/P and additional birth defects in South America. Given the large healthcare and financial burden of CL/P on affected families and the relatively low cost of systematic pediatric care, improving access to such care may be a cost-effective public policy intervention.
Trial Registration
ClinicalTrials.gov: NCT00097149
doi:10.1186/1471-2431-11-121
PMCID: PMC3277464  PMID: 22204448
9.  Complementary feeding: a Global Network cluster randomized controlled trial 
BMC Pediatrics  2011;11:4.
Background
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.
Methods/Design
A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.
Discussion
Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.
Trial registration
NCT01084109
doi:10.1186/1471-2431-11-4
PMCID: PMC3032692  PMID: 21232139
10.  Antioxidant Supplementation and Premature Rupture of the Membranes: A Planned Secondary Analysis 
Objective
To determine if antioxidant supplementation during pregnancy reduces the incidence of premature rupture of the membranes (PROM).
Study Design
A placebo-controlled, double-blind trial was conducted. PROM and preterm PROM (PPROM) were planned secondary outcomes of the trial. Women between 120/7 and 196/7 weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomized to daily treatment with both vitamin C (1000 mg) and E (400 IU) or placebo.
Results
Outcome data for PROM were available for 697 of 739 patients. The rates of PROM 37/349 [10.6%] versus 19/348 [5.5%]; adjusted risk ratio [RR] 1.89 [95.42% confidence interval CI) 1.11, 3.23]; p=0.015), and PPROM (16/349 [4.6%] versus 6/348 [1.7%]; RR 2.68 [1.07, 6.71]; p=0.025) were increased in the antioxidant group.
Conclusion
Contrary to expectations, vitamins C and E supplementation in this dose combination may be associated with an increased risk of PROM and PPROM.
doi:10.1016/j.ajog.2008.07.011
PMCID: PMC2723730  PMID: 18928997
antioxidants; prematurity; premature rupture of the membranes; prevention; vitamin C; vitamin E
11.  Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149] 
BMC Pediatrics  2006;6:9.
Background
The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally.
Methods/Design
We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions.
Discussion
Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight.
doi:10.1186/1471-2431-6-9
PMCID: PMC1552061  PMID: 16563165
12.  A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627] 
BMC Women's Health  2005;5:4.
Background
A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples.
Methods/Design
The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.
doi:10.1186/1472-6874-5-4
PMCID: PMC1090598  PMID: 15823211

Results 1-12 (12)