View clinical trials related to Birth Weight.
Filter by:This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants.
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - <20 weeks gestation), and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels, and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. The researchers estimate that 15% of households will have a second, non-pregnant older adult woman (aged 40 to <80 years) who will also be enrolled at baseline and followed during the 18-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and blood pressure in the older adult woman. Secondary outcomes include preterm birth and development in the child, maternal blood pressure during pregnancy, and endothelial function, respiratory impairment, atherosclerosis, carcinogenic metabolites, and quality of life in the older adult woman. Participants in India, Guatemala and Rwanda will be followed until the child is 5 years old to assess the longer-term effects of the intervention.
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants < 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants < 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.
Intrauterine growth restriction ( IUGR )is defined as fetal growth slower than the normal growth potential of a specific fetus because of genetic or environmental factors. Recently several studies have highlighted the role of many biomolecules as markers for IUGR. Measurement of maternal serum ferritin has also been used as a predictive marker for increased risk of IUGR. Iron deficiency has its known deleterious effect in pregnancy but iron loading may be associated with oxidative damage to cells and tissues. It has been shown in various studies that lower level of transferritin receptor expression in placenta is associated with preeclampsia and IUGR. This can lead to decrease extraction of iron by placenta from maternal serum leading to increase maternal serum ferritin. This fetal iron deficiency leads to increase in fetal corticotropins and fetal cortisol, causing inhibition of fetal growth
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.
A nutrition trial which is based on the evidence that multivitamins & micro nutrients provided during pregnancy in malnourished women will improve neonatal birth weight. There will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI <20 & gestational age less than 14 weeks. The other arm with same criteria will be provided with wheat flour, oil, iron & folic acid. Neonatal birth weight is the primary outcome of interest but maternal weight gain, maternal hemoglobin & ferritin levels and palatability of biscuits will also be assessed.
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates. During their stay in the neonatal intensive care unit an increased supply with energy, protein and electrolytes is necessary to establish adequate growth. After discharge from the hospital special breast milk supplements or post discharge formulas are available to cover the special nutrient requirements. Complementary feeding in preterm infants is an unexplored field so far and nutritional concepts for the first year of life are not available. Data concerning the optimal time for starting solid foods are missing as well as information concerning the ideal composition of complementary food. In this context it is essential to meet the special nutritional needs of "Ex-Preemies" on the one hand and avoid overfeeding and later obesity on the other hand. So far it remains unclear, what the "safe" time point for introduction of solid food to premature infants is and whether this time point influences growth, body composition, neurodevelopmental outcome or the incidence of atopic disease.
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.