View clinical trials related to Birth Weight.
Filter by:The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU. The main question it aims to answer is: 1) is there an optimal position for an infant to be held during KMC and 2) to optimise benefits for infants receiving KMC. Participants will be: 1) randomised into two groups which determine which angle they will start at first, 2) assessed over two hour-long sessions on different days with a change in the angle at the 30 minute point, 3) monitored using a Massimo NIRS machine which will record oxygen saturations, cerebral NIRS values and heart rates, and 4) monitored for any episodes of desaturations and bradycardias during this time. Participants will then be assessed beginning with the the other angle first on a different day. The researchers will then compare the two groups to see if being held at a 30 degrees during KMC is superior to being held at 60 degrees in terms of physiological stability.
The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. There are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (BWDT). BWDT was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. Existing studies mainly focus on the perinatal outcomes of mothers and infants with BWDT, or are reported from small samples in developed countries. The investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in China with a large sample. Through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of BWDT, and analyze its adverse outcomes.
Low birth weight (LBW) infants are at significantly elevated risk for a host of detrimental outcomes including cognitive, language, and social delays and disabilities, which persist into adulthood. An important protective factor for mitigating risk is sensitive and responsive parenting. While evidence- based home visiting interventions exist and were developed specifically for LBW infants, such as the Play and Learning Strategies program, parents face major obstacles in accessing these interventions. In general, interventions demonstrated to be effective through federal research are very slow to migrate to community service delivery systems. Exacerbating this problem currently is the fact that while VLBW has been increasing, and disproportionately so for those who are poor an of minority status, home visiting programs have sustained some of the largest cuts in their histories. Consequently, there is high demand for effective interventions that can be delivered remotely. Through prior, the investigator team addressed this need by adapting the evidence-based PALS program for web-based delivery using laptop computers with streaming video of in-home parent child interactions and weekly remote coaching. The investigator team then rigorously tested its effects in a sample of low-income mothers and infants with typical birth histories. Results of this randomized controlled study showed pre-post growth in maternal sensitivity behaviors and significant increases in infants' social engagement with their mothers, with moderate to large effect sizes for the intervention group as compared to the control group. These encouraging results provide a strong empirical basis for the enhanced web-based delivery method of the PALS program. Although PALS was originally developed and tested with LBW infants, the web-based version, InfantNet, has not yet been tested with this population. Moreover, emergent trends show that young Latino and Black women most often access the Internet through smart phones, not laptops. Consequently, there is great demand for improving access to evidence-based interventions by making them available on mobile devices such as smart phones. Response: To address the need for more accessible evidence-based interventions, the investigator team will overlay the InfantNet program onto the iPhone and rigorously test its effects with 60 low- income mothers and their LBW infants through a 2-arm, 3 cohort, randomized-controlled design.
Background: The burden of preterm and low birth weight babies (LBW) is high in low- and middle-income countries (LMICs). Therefore, assessment of gestational age (GA) and birth weight is important. The GA is assessed using a reliable last menstrual period (LMP), measuring fundal height, using ultrasound for dating, or postnatally using Ballard, Dubowitz, or Eregie scores. However, each method has some limitations. Pregnant women in LMIC are not able to recall LMP and are also unreliable when menstrual cycles are irregular, fundal height is often imprecise and subject to variation due to observer bias, uterine pathologies, abdominal obesity, amniotic fluid volume, fetal position, and ultrasound in a rural setting is often unreliable because lack of trained sonologist, power failures, and maintenance of ultrasound machine. Post-natal GA scoring is also lengthy, subjective, and time-consuming. Similarly, determining birth weight has many challenges. In Thatta, weighing scales are only available in health facilities, therefore, birth weight is available for babies born in the health facilities. Furthermore, even where weighing scales are available, the calibration and maintenance are not without challenges, especially in the extremely hot climate. In the majority of studies, foot length has been validated for determining GA and birth weight, with LMP serving as the gold standard, which has limitations in our population. In a meta-analysis on the diagnostic accuracy of foot length to identify preterm and LBW, researchers emphasized the need for studies using high-quality ultrasound as a reference standard for early dating. Hence, there is a need to develop a simple and effective method of GA and birth weight that healthcare providers of all levels including mid-level healthcare workers in remote areas can use with reasonable accuracy. Objectives of the study The primary objectives of the study are to determine the diagnostic accuracy of foot length in predicting GA and low birth weight using ultrasound conducted between 6-20 weeks for the predicted estimated date of delivery (EDD) as the gold standard. Secondary objectives of the study are, 1) to develop the regression equations that predict gestational age and low birth weight using foot length, 2) to assess the use of foot length measurement as a screening tool to identify LBW or preterm infants in a community-based setting, and 3) to develop percentile charts of foot length for gestational age and low birth weight Methods: This test validation study will be conducted in Global Network's Maternal and Newborn Health Registry catchment area. All live birth singleton babies who have a first-trimester ultrasound for gestational age and birth weight within 48 hours of birth will be included in this study. Stillbirths, multiple pregnancies, gross congenital malformations such as neural tube defects, omphalocele, etc., club foot, and babies with chromosomal abnormalities such as Down syndrome that make measuring foot length difficult, will be excluded from the study. Gestational age will be assessed using ultrasound between 6-20 weeks of gestation by a trained sonographer working in the registry. Neonatal assessment having neuromuscular, and physical signs will be conducted by the research assistants (RA). RA will be taking anthropometric measurements such as birth weight using calibrated weighing scales, foot length, mid-upper arm circumference, and fronto-occipital circumference. The data will be entered in Epicollect data five. Sensitivity, specificity, positive & negative predictive value, likelihood ratios, and diagnostic accuracy will be done using different cut-offs of foot length against ultrasound estimated gestational age and birth weight. Receivers operating characteristics (ROC) curves will be generated to identify the optimal cut-off point for foot length taken within 24 hours of birth for identification of prematurity and LBW (based on first-trimester ultrasound) with ≥80% sensitivity. Linear regression will be done for estimating predictive values of foot length by GA. Pentile charts for foot length (FL) against GA will be derived. Bland Altman's analyses will identify and quantify any biases inherent to the tool. Public health implications: If these equations predict gestational age and birth weight with accuracy, an android-based application can be developed for health care providers (HCP) who simply measure foot length and enter it into the application to identify preterm &/or low birth weight along with referred guidelines for early treatment. This is one step closer to Every Newborn Action Plan's goal of lowering neonatal mortality to 12/1000 LB by 2030.
This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.
Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.
Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. Anemia rates are among the highest in South Asia, with a recent national survey indicating that over half of pregnant women in India are classified as anemic. For nearly 40 years, India's first-level treatment for anemia in pregnancy has been oral iron; however, side effects, poor adherence to tablet ingestion, and low therapeutic impact are among reasons to consider a new paradigm for treatment of pregnant women with iron deficiency anemia (IDA). Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial is a 3-arm, randomized-controlled trial designed to assess if a single dose of an intravenous (IV) iron formulation, administered early in the second trimester of pregnancy for treatment of moderate IDA, will result in a greater proportion of participants in the IV iron arms achieving a normal hemoglobin concentration in the third trimester when compared to participants randomized to receive oral iron. This trial is also designed to test the hypothesis that the low birth weight (LBW) rate for participants randomized to the IV iron arms will be lower when compared to the LBW rate of those randomly assigned to the oral iron arm. The three arms include two IV iron arms (arm 1 - ferric carboxymaltose, arm 2 - iron isomaltoside, also known as ferric derisomaltose) and an active, comparator arm receiving oral iron, which is the standard of care. This study will be conducted in two states in India - Karnataka and Rajasthan. This study supports the overall goals of the Indian Ministry of Health and Family Welfare for pregnancy care; thus, all study participants will be followed according to the Ministry's antenatal care guidelines, and data will be collected through 42 days post-delivery. (see attached protocol for more detail)
This is a retrospective single-center cohort study. The comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.
- Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. - Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life. - Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status. - There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants. - Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.