Infant Body Weight Research Articles

Perinatal lead (Pb) exposure results in sex-specific effects on food intake, fat, weight, and insulin response across the murine life-course.

Developmental lead (Pb) exposure has been associated with lower body weight in human infants and late onset obesity in mice. We determined the association of perinatal Pb exposure in mice with changes in obesity-related phenotypes into adulthood. Mice underwent exposure via maternal drinking water supplemented with 0 (control), 2.1 (low), 16 (medium), or 32 (high) ppm Pb-acetate two weeks prior to mating through lactation. Offspring were phenotyped at ages 3, 6, and 9 months for energy expenditure, spontaneous activity, food intake, body weight, body composition, and at age 10 months for glucose tolerance. Data analyses were stratified by sex and adjusted for litter effects. Exposed females and males exhibited increased energy expenditure as compared to controls (p<0.0001 for both). In females, horizontal activity differed significantly from controls (p = 0.02) over the life-course. Overall, food intake increased in exposed females and males (p<0.0008 and p<0.0001, respectively) with significant linear trends at 9 months in females (p = 0.01) and 6 months in males (p<0.01). Body weight was significantly increased in males at the medium and high exposures (p = 0.001 and p = 0.006). Total body fat differed among exposed females and males (p<0.0001 and p<0.0001, respectively). Insulin response was significantly increased in medium exposure males (p<0.05). Perinatal Pb exposure at blood lead levels between 4.1 µg/dL and 32 µg/dL is associated with increased food intake, body weight, total body fat, energy expenditure, activity, and insulin response in mice. Physiological effects of developmental Pb exposure persist and vary according to sex and age.

Daily physical activity in low-risk extremely low birth weight preterm infants: positive impact on bone mineral density and anthropometric measurements.

The aim of this study was to evaluate the changes in bone mineral density and anthropometric indices of extremely low birth weight (ELBW) preterm infants undergoing daily physical activity. Twenty-eight low-risk ELBW preterm infants (intervention group = 14, control group = 14) with a birth weight of under 1000 g and gestational age of 26-32 weeks were recruited. Preterm infants in the control group were provided with standard nursing care, whereas those in the intervention group received a daily physical activity programme in addition to standard nursing care during the study. Before and after the study, anthropometric indices and tibial speed of sound (SOS) values were measured. In this study, the tibial SOS values were found to be increased in the intervention group (+111.14 m/s) (p = 0.001) and decreased in the control group (-58.21 m/s) (p = 0.030). The increase in percentage of body weight, height, and tibial length of infants in the intervention group was significantly higher than in the control group (respectively; p = 0.002, p = 0,015, p < 0.001). A daily physical activity programme increased body weight, height, tibial length, and SOS values of the tibia in ELBW preterm infants.

Kejadian malaria dan status gizi balita di Kabupaten Manokwari Provinsi Papua Barat

Background: The prevalences of severe acute malnutrition, moderate acute malnutrition and low birth weight (LBW) in West Papua Province is higher than the national prevalence. Malaria disease, especially in an infant, is also of concern in this province. Manokwari District is regarded as malaria endemic area due to the high morbidity rate in the entire district.Objective: To determine the incidence of malaria, nutritional status of children and to analyze the relationship between two of them.Method: The methodology that used in this research is cross-sectional design conducted in four health centers in Manokwari with a sample of 100 children aged two to five years. The data were analyzed using Chi-Square analysis and logistic regression analysis.Results: The incidence rate of malaria in Manokwari district is high. This is because the number of an infant that was infected highly and lowly by malaria do not vary much. Results show that 42% children suffering from severe malaria, particularly tropical malaria type, with a frequency of more than two times in six months so that it had a direct effect on appetite and weight. Average nutritional status based on weight/height and height/age is normal while according to weight/age is not normal. Infants with severe and moderate acute malnutrition are not found in this study.Conclusion: The incidence rate of malaria in children under five in the district of Manokwari is high, the nutritional status of children under five in the past are in the normal category and at the time of the study were not normal, this is due at the time of the study many infants experience pain and therefore contributes to the appetite that directly affects body weight of infants. Furthermore, it is known that there is a relationship between the incidence of malaria by the nutritional status of children in the district of Manokwari.

Outcome of low body weight (

IntroductionInfants with low body weight (LBW) following cardiac surgery are a major challenge for the post cardiac surgery care unit. It has been observed that post surgery outcome for LBW infants is worse compared to the outcome of normal body weight infants. A study was conducted to compare post operative course and outcome of infants with body weight of 2.2kg or less against infants with normal body weight who underwent similar cardiac surgeries. MethodsA retrospective review was performed for all infants below 2.2kg who underwent cardiac operations at King Abdulaziz Cardiac Center from January 2001 to October 2011. Cases with LBW (Group A) were compared with matching group (Group B) of normal body weight infants who had similar cardiac surgeries and matching surgical risk category. The demographic, ICU parameters, complications, and short-term outcome of both groups were analyzed. ResultsTwo groups were formed, with 37 patients in Group A, and 39 patients in Group B. Except for weight (2.13±0.08kg in Group A vs 3.17±0.2kg in Group B), there was no statistical difference in demographic data between both groups. Cardiac procedures included coarctation repair, arterial switch, ventricular septal defect (VSD) repair, tetralogy of Fallot repair, systemic to pulmonary shunt and Norwood procedures. Patients in Group A had statistically significant difference from Group B in terms of bypass time (p=0.01), duration of inotropes (p=0.01), duration of mechanical ventilation (p=0.004), number of re-intubations (p=0.015), PCICU length of stay (p=0.007), and hospital mortality: 13.5% in Group A vs 0% in Group B (p value 0.02). ConclusionPatients with LBW (<2.2kg) underwent cardiac surgery with overall satisfactory results, but with increased risk of ICU morbidity and mortality.

Development of High-Sensitive ELISA Method for Detection of Adipophilin Levels in Human Colostrum and Breast Milk

To develop and validate high-sensitive (hs) ELISA method for detection of adipophilin (adipose differentiation-related protein, ADRP) in human breast milk (BM) and to analyze adipophilin levels in BM during 12 months of lactation. ADRP levels were determined using hsELISA method (Biovendor-Laboratory Medicine, Inc.) in colostrum (D0) and BM of 72 mothers was collected 1, 3, 6, and 12 months following delivery (M1, 3, 6, 12). ADRP was detectable in BM up to 12 months of lactation. Mean levels at D0 were 1.98 ± 0.12; M1, 2.83 ± 0.21; M3, 2.39 ± 0.17; M6, 2.57 ± 0.16; and at M12 3.25 ± 0.21 μg/ml. Significantly higher levels of ADRP were found in M1 and M12 when compared to D0 and in M12 when compared to M3 (overall P = 0.0001). No significant correlation was seen between ADRP levels in BM and adiponectin, body weight of infants, their birth length, body weight gain during the first year of life, or BMI of mothers before pregnancy. We developed and validated hsELISA for detection of ADRP in human BM. ADRP was detectable in human BM during the whole 12 months of lactation period and its levels were intraindividually well-conserved.

Association between aflatoxin M1 exposure through breast milk and growth impairment in infants from Northern Tanzania

Infants breastfeeding from mothers consuming aflatoxin contaminated foods may be exposed to aflatoxin M1 (AFM1), a metabolite of aflatoxin B1. This study estimated the association between AFM1 exposure levels and growth indicators, for infants under six months of age in the Rombo district in Northern Tanzania. A total of 143 infants and their mothers were involved. Breast-milk samples, infants' anthropometric data and 24 h dietary recall for mothers were taken at the 1st, 3rd and 5th months of children age. AFM1 contaminations in the samples were determined using HPLC. Aflatoxin M1 exposure by an infant was estimated by multiplying contamination in the breast milk consumed by him/her with the breast milk intake recorded by the United States Environmental Protection Agency for infants of his/her age divided by the infant's body weight. All the breast-milk samples were contaminated by AFM1 at levels ranging from 0.01 to 0.55 ng/ml. Above 90% of samples exceeded the EU limit of 0.025 ng/ml for infants' foods while over 76% exceeded the EU limit of 0.05 ng/ml for dairy milk and milk products. Only 1% of the samples exceeded the limit of 0.5 ng/ml set for dairy milk in the United States and several countries in Asia. AFM1 Exposures ranged from 1.13-66.79 ng/kg body weight per day. A small but significant (P&lt;0.05) inverse association was observed between AFM1 exposure levels and weight for age Z-score or height for age Z-score. Appropriate strategies should be applied to minimise aflatoxin B1 exposure in lactating mothers in order to protect infants from AFM1 exposure.

Embolization of pulmonary sequestration with Onyx: an unusual application

We report a baby with intralobar pulmonary sequestration who was successfully treated with a new embolization agent, Onyx. A 1.5-month-old female infant was admitted to our hospital with sweating and fatigue. Telecardiography showed cardiomegaly, dextrocardia, and increased pulmonary vascular markings. In thoracic computerized tomography, pulmonary sequestration, right pulmonary hypoplasia, and large collateral arteries were seen. The collateral arteries were originating from the celiac trunk and aorta. Echocardiography revealed enlargement of the left atrium and ventricle and left ventricle systolic dysfunction. Angiography revealed a large feeding artery and three branches originating from the aorta and another feeding artery originating from the celiac trunk. We performed embolization of the feeding arteries and their branches, with coils and Onyx. The procedure was performed without complications, and all feeding arteries were completely occluded. The infant started to gain weight. One year later, the infant's body weight had increased and she had no respiratory problems or signs of congestive heart failure. In this case report, we suggest that embolization with Onyx is a reliable alternative method to surgery for infants with pulmonary sequestration. With future studies, pulmonary sequestration embolization with Onyx may become an acceptable and easy treatment option in pediatric patients.

Changes in the body weight of term infants, born in the tropics, during the first seven days of life

BackgroundIdentifying unwell neonates, particularly in the first week of life, is often subjective. If normal values are known, calculating the weight lost or gained from birth weight can be a useful adjunct in the evaluation of the health of a neonate.MethodsSerial body weights of well, term, breast fed infants who were attending for routine follow up, were recorded at the Shoklo Malaria Research Unit clinic in Maela Camp for displaced persons on the Thailand Myanmar border. Newborn examination was routine. Weight loss, expressed as percent weight lost from birth weight, and weight gain, expressed as a velocity (g/kg/day), was calculated for the first seven days of life. The results from normal birth weight infants, low birth weight infants (<2.5 kg) and small for gestational age infants (SGA) were examined.ResultsIn the first week of life there were no significant differences in weight gained or lost across the three study groups. The maximum weight lost was 4.4% (95% CI 4.1 – 4.6%), which occurred on day three. Weight gain ranged from 13 g/kg/day [95% CI 10 – 16] on day four to 18 g/kg/day [95% CI 15 – 20] on days six and seven.ConclusionsUse of these normal values for weight gain and loss, allows infants falling outside of the expected range (95% CI) to be easily identified and subsequently highlighted as needing further medical review.

The diameter of the inferior vena cava provides a noninvasive way of calculating central venous pressure in neonates

To explore a less invasive way of assessing preload in neonates than fitting catheters to measure central venous pressure (CVP). This study evaluated the relationship between inferior vena cava (IVC) measurements and gestational age (GA) or body weight (BW) in term and premature infants and the correlation between those measurements and CVP in sick infants under mechanical ventilation. We studied 57 clinically stable infants, together with 14 sick infants fitted with central venous catheters to measure CVP. Subcostal transverse views were recorded at the level of the left branch of portal vein, and the minimum (DS ) and maximum (DL ) diameters of the IVC were measured. We evaluated the values of DS and DL and the S/L ratio (DS divided by DL ) in the clinically stable infants and the correlation between S/L and CVP in the sick infants with central catheters. DS and DL correlated positively and strongly with both GA and BW, whereas S/L was almost independent of both GA and BW and correlated strongly with CVP. At the subcostal transverse views, S/L is much less affected by either GA or BW than DS or DL and correlates strongly with CVP in mechanically ventilated infants.

Prevention of intraoperative hypothermia in neonates and infants: results of a prospective multicenter observational study with a new forced‐air warming system with increased warm air flow

Neonates and infants are at the highest risk of developing perioperative hypothermia. A number of methods to prevent hypothermia during pediatric anesthesia are in use, and despite the fact that conventional forced-air warmers are the most effective devices, they are not always sufficient enough to maintain body temperature. Therefore, recently a new forced-air warming system with an increased warm air flow was introduced to the market. The aim of this study was to evaluate this new forced-air warming system in neonates and infants during pediatric anesthesia. We hypothesized that the new blanket alone is sufficient enough to prevent neonates and infants from intraoperative hypothermia. Neonates and infants (body weight <10 kg) were enrolled in this prospective multicenter observational study. After admission to the operating room, the children were placed on the new forced-air warming blanket. Body temperature was measured continuously until admission to the recovery room or pediatric intensive care unit (PICU). Hundred and nineteen children with a median body weight of 4.1 kg (range: 0.7-9.8) were enrolled and received their intended treatment. Median body temperature at the induction of anesthesia was 36.5 °C (range: 35.3-38.2 °C) and increased with the length of the operation up to 37.8 °C (37.1-38.2 °C) after 180 min. Median body temperature after admission to the recovery room or PICU was 37.2 °C (36.0-38.6 °C) and remained significantly above baseline (P < 0.05). The new forced-air warming system as a sole warming device is effective in preventing perioperative hypothermia during pediatric anesthesia in neonates and infants.

Impact of leg length and body mass on the stride length and gait speed of infants with normal motor development: A longitudinal study

Gait acquisition is supported by changes in the neuromusculoskeletal system of the child. Changes in the dimensions of the body structures resulting from the growth of the child partly explain gait improvement in the first year of life. To evaluate whether changes in body mass and leg length modulate the effect of independent gait practice (experience) on gait speed and stride length. Thirty-two infants with normal development were monitored monthly from the acquisition of independent gait until six months post-acquisition. Longitudinal evaluations included measurements of the body mass and leg length of each child. Temporospatial variables of gait (speed and stride length) were documented using the Qualisys Pro-reflex(r) system. The data were analyzed using multilevel regression models, with a significance level of α=0.05. An effect of the practice time on speed (p<0.0001) and stride length (p<0.0001) was observed. The change in leg length had a marginal effect on the rate of gait speed change: children whose leg growth was faster showed a higher rate of speed change (p=0.07). No other effects of anthropometric parameters were observed. The results suggest that the practice time promotes the improvement of the gait pattern of infants in the first year of life. However, the effects of the leg length and body weight of infants on the benefit of practice time remain undefined.

Post-operative ICU course of infant below 2.2 kg undergoing cardiac surgery

Introduction Infants with low body weight (LBW) are major challenges for post cardiac surgery care. We conducted this study to compare post-operative course and outcome of infant weighing 2.2 kg or less with matching group of infants with normal body weight who underwent similar cardiac surgery. Methods We reviewed retrospectively all infants below 2.2 kg who underwent cardiac operation at our institution from January 2001 to March 2011. Cases with LBW (group A) were compared with matching group (group B) of normal body weight infants who had similar cardiac surgery and matching surgical risk category. We compared demographic, ICU parameters, complications and short-term outcome of both groups. Results Thirty seven patients were included in group A and 39 in group B. Except for Weight (2.13 ± 0.08 kg in group A vs. 3.17 ± 0.2 kg in group B); there was no statistical difference in demographic data between both groups. Cardiac procedures included coarctation repair, Arterial switch, VSD repair, tetralogy of Fallot repair, systemic to pulmonary shunt and Norwood procedures. Patients in group A had statistically significant difference from group B in term of bypass time ( p = 0.01), duration of inotropes ( p = 0.01), duration of mechanical ventilation ( p = 0.004), number of re-intubations ( p = 0.015), PCICU length of stay ( p = 0.007) and mortality (13.5% in group A vs. 0% in group B, p value 0.02). Conclusion Patients with LBW below 2.2 kg can go for cardiac surgery with overall satisfactory result but with increase risk of ICU morbidity and mortality.

Effect of dietary intervention to reduce the n-6/n-3 fatty acid ratio on maternal and fetal fatty acid profile and its relation to offspring growth and body composition at 1 year of age

Evidence is accumulating that the long-chain PUFA (LCPUFA) are associated with offspring growth and body composition. We investigated the relationship between LCPUFAs in red blood cells (RBCs) of pregnant women/breastfeeding mothers and umbilical cord RBCs of their neonates with infant growth and body composition ≤ 1 year of age. In an open-label randomized, controlled trial, 208 healthy pregnant women received a dietary intervention (daily supplementation with 1200 mg n-3 LCPUFAs and dietary counseling to reduce arachidonic acid (AA) intake) from the 15th week of gestation until 4 months of lactation or followed their habitual diet. Fatty acids of plasma phospholipids (PLs) and RBCs from maternal and cord blood were determined and associated with infant body weight, body mass index (BMI), lean body mass and fat mass assessed by skinfold thickness measurements and ultrasonography. Dietary intervention significantly reduced the n-6/n-3 LCPUFA ratio in maternal and cord-blood plasma PLs and RBCs. Maternal RBCs docosahexaenoic acid (DHA), n-3 LCPUFAs and n-6 LCPUFAs at the 32nd week of gestation were positively related to birth weight. Maternal n-3 LCPUFAs, n-6 LCPUFAs and AA were positively associated with birth length. Maternal RBCs AA and n-6 LCPUFAs were significantly negatively related to BMI and Ponderal Index at 1 year postpartum, but not to fat mass. Maternal DHA, AA, total n-3 LCPUFAs and n-6 LCPUFAs might serve as prenatal growth factors, while n-6 LCPUFAs also seems to regulate postnatal growth. The maternal n-6/n-3 LCPUFA ratio does not appear to have a role in adipose tissue development during early postnatal life.

Plasma Fatty Acids in Premature Infants With Hyperbilirubinemia

Infants who are dependent on parenteral nutrition (PN) sometimes develop PN-associated cholestasis (PNAC). A compassionate use protocol, approved by the U.S. Food and Drug Administration and the institutional review board, guided enrollment of hospitalized infants with PNAC (<1 year of age, PN dependence for >3 weeks). Plasma concentrations of essential fatty acids were monitored before and after a soybean-based PN lipid, infused at 3 g/kg body weight/d, was replaced by an experimental fish oil-based intravenous fat emulsion (FO-IVFE) at 1.0 g/kg/d. All participants were born premature (n = 10; 20% male). At enrollment, infants were (mean ± SD) 86.5 ± 53.5 days of life and weighed 2.24 ± 0.87 kg; direct bilirubin was 5.5 ± 1.3 mg/dL. After treatment, blood concentrations significantly increased from baseline (P < .017) for circulating eicosapentaenoic acid (6.3 ± 3.0 to 147.8 ± 53.1 µg/mL), docosahexaenoic acid (20.7 ± 6.5 to 163.7 ± 43.4 µg/mL), pristanic acid (0.01 ± 0.01 to 0.17 ± 0.03 µg/mL), and phytanic acid (0.06 ± 0.03 to 0.64 ± 0.15 µg/mL). In contrast, total plasma ω-6 fatty acids (including linoleic acid) decreased (P < .017). The triene/tetraene ratio remained below the threshold value of 0.2 that defines ω-6 deficiency. No adverse effects were observed attributable to FO-IVFE. Discontinuation of FO-IVFE was typically due to infants (body weight 3.76 ± 1.68 kg) transitioning to enteral feeding rather than for resolution of hyperbilirubinemia (direct bilirubin 7.9 ± 4.8 mg/dL). These exploratory results suggest that FO-IVFE raises circulating ω-3 fatty acids in premature infants without development of ω-6 deficiency in the 8.3 ± 5.8-week time frame of this study.

Efficacy of the Screening Algorithm WINROP in a Korean Population of Preterm Infants

To investigate the efficacy of WINROP (https://winrop.com), an algorithm based on serial measurements of neonatal body weight to predict proliferative retinopathy of prematurity (ROP), in a Korean population of preterm infants. The records of preterm infants with gestational age less than 32 weeks who were admitted to the neonatal intensive care unit at Chonnam National University Hospital, Gwangju, South Korea, from October 2006 to November 2010 were reviewed. The body weight of infants was measured weekly and entered into a computer-based surveillance system, WINROP, and the outcome was analyzed. A total of 314 preterm infants participated in the study. The mean gestational age was 29 weeks (range, 25-32 weeks). The mean body weight was 1263 g (range, 590-2260 g). For 166 of 314 infants (52.9%), a high-risk alarm was noted. In the high-risk alarm group, 36 infants developed type 1 ROP, according to the Early Treatment for Retinopathy of Prematurity criteria, and they were treated for ROP. The remaining 148 infants (47.1%) had a low-risk alarm. In the low-risk alarm group, 3 infants with bronchopulmonary dysplasia and intraventricular hemorrhage, a risk factor for ROP, and 1 infant without any risk factors for ROP developed type 1 ROP and were treated. In a Korean population, the WINROP algorithm had a sensitivity of 90% for identifying infants with type 1 ROP. Although some limitations are present, adjustment to the WINROP algorithm for a specific population may improve the efficacy of predicting proliferative ROP and reduce the frequency of retinal examinations.

1369 Neonatal Morbidity in Hypertensive Pregnancy

Research conducted at the Gynaecology-obstetrics and neonatology department of the Health Center Vranje in 2011./2012 included 80 mothers and 80 infants. The study included 40 mothers of patients with hypertensive...

1659 Post - Operative ICU Course of Infant Below 2.2 Kg Undergoing Cardiac Surgery

IntroductionInfants with low body weight (LBW) are major challenges for post cardiac surgery care. We conducted this study to compare post-operative course and outcome of infant weighing 2.2 Kg or...

Cardiovascular computed tomography angiography in newborns and infants with suspected congenital heart disease: retrospective evaluation of low-dose scan protocols

Twelve infants (body weight, 3.59±1.36 kg) with congenital heart disease underwent a clinically indicated cardiovascular computed tomography angiography (CTA) study. Retrospectively, we investigated the feasibility and diagnostic capability of different non-electrocardiogram-triggered CTA protocols and assessed radiation doses.Scans were performed on a 256-multislice CT (MSCT) scanner with the vendor-preset helical protocol at 120 kV for babies, with axial single-shoot scans at 120 kV and 80 kV. The 80-kV protocol led to significantly reduced mean effective doses of 0.29±0.08 mSv (P=.017) and renders diagnostic image quality. All major cardiovascular defects were detected on MSCT, and all images were of diagnostic quality.

Incidence, risk factors, and treatment of retinopathy of prematurity among very low birth body weight infants

PurposeThis study was conducted to determine the incidence, risk factors, and treatment for retinopathy of prematurity (ROP) among very low birth weight (VLBW) infants. MethodsThis work is a retrospective, observational analysis of all VLBW infants managed at National Taiwan University Hospital from 2002 to 2005. ResultsThe chart data of 96 VLBW infants were reviewed. Seven of the 96 infants (7.3%) were noted to have no ROP, while 18 infants (18.7%) had minor ROP (stage 1 and stage 2 ROP) and 71 infants (74%) had severe ROP (greater than stage 2 ROP). With lower gestational age, lower birth body weight, greater degree of respiratory distress syndrome, prolonged use of oxygen, and without maternal history of antenatal steroid use, the incidence of severe ROP (greater than stage 2) increased significantly (p < 0.001, p < 0.001, p = 0.01, p < 0.001, and p = 0.03, respectively). ConclusionMore severe ROP may correlate with lower gestational age, lower birth body weight, and longer oxygen use. Use of antenatal steroid would decrease the incidence of severe ROP.

Comparative efficacy of uncontrolled and controlled intermittent preventive treatment during pregnancy (IPTp) with combined use of LLTNs in high resistance area to sulfadoxine-pyrimethamine in C&amp;ocirc;te d&amp;rsquo;Ivoire

IntroductionIn recent years, intermittent preventive treatment for pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) has become policy in much of sub-Saharan Africa. But resistance to SP has been spreading across sub-Saharan Africa and thus the effectiveness of IPTp-SP has been questioned. The present study therefore sought to assess the incidence of placental malaria, low birth weight, and anemia of two IPTp-SP approaches (directly observed treatment scheme versus no directly observed treatment) in Anonkoua-Kouté and Samo, Côte d’Ivoire where the reported prevalence of dfr single mutant 108 was 62% and 52.2%, respectively.MethodsThe study was a longitudinal design involving pregnant women and was conducted in Anonkoua-Kouté, a suburban area, and Samo, a rural area, from January 2008 through March 2009. Women of a pregnancy less than 28 weeks duration were randomized to receive SP (1.5 g/0.075 g SP) in a single intake twice and were followed up monthly until delivery. Doses were administered under supervision in the controlled IPTp group, while SP was given free to women in the uncontrolled IPTp group with a recommendation to take it at home. The primary end point was the proportion of low birth weight infants (body weight < 2500 g) and the secondary end point was the rate of severe anemia and placental malaria detected at delivery.ResultsA total of 420 pregnant women were enrolled (212 and 208, respectively, in the controlled and uncontrolled groups). Delivery outcome was available for 378 women. In the modified intention-to-treat analysis, low birth weight infants were born from 15.5% of women of the uncontrolled IPTp group and from 11.9% of women in the controlled IPTp group (P = 0.31). The per-protocol population analysis showed consistent results. The proportion of women with placental malaria infection, moderate anemia (hemoglobin < 11 g/dL), and severe anemia (hemoglobin < 8 g/dL) at delivery were similar between the two groups (P > 0.05).ConclusionThe study showed that the two approaches were equivalent, suggesting that unsupervised IPTp-SP free of charge should be used in areas where implementation of the directly observed treatment scheme suffers from many constraints.