View clinical trials related to Birth Weight.
Filter by:More than 20 million infants worldwide, representing 16 per cent of all births, are born with low birth weight, 96 per cent of them in developing countries. Bangladesh having one of the highest incidence rate (21.6%) in the world.The short-term consequences of LBW is 12 times higher perinatal mortality. It is estimated that LBW causes 60 to 80 % of neonatal deaths. For the survivors, the effects are long lasting and largely irreversible. Infants born LBW are at 2-4 times greater risk to develop acute diarrhea, pneumonia or acute respiratory tract infection than their normal birth weight counterparts. Adults born with LBW suffer increased risk of high blood pressure, coronary heart disease (CHD), non insulin dependent diabetes mellitus, obstructive lung diseases, or renal damage. Genitourinary (GU) infection, as a major risk factor for low birth weight deliveries affecting a very large number of women both in the industrialized and the developing world. In Bangladesh, there was a high incidence of UTI in 21-25 years age group (44.61%). The bottom line for GU infection is that lactobacilli, healthy bacteria lose their dominant. Recently, the protective role of the commensal microbiota has come into focus for its infection-inhibiting function. Lactobacilli that colonize the gastrointestinal tract or vagina can either significantly modulate the colonic microbiota by increasing the number of specific prebiotic bacteria such as lactobacilli and bifidobacteria or reducing undesired intestinal colonization of pathogenic bacteria. Prebiotic like Fructooligosaccharide (FOS) is known to promote growth of normal healthy flora like lactobacilli (LAB). FOS supplementation in early pregnancy improves vaginal or gut microflora with LAB , which will control GU infection and improve pregnancy outcome and promote infant's growth and development
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation between gene expression, oral somatosensory stimulation, feeding behavior, and neurodevelopmental outcomes at 18 months corrected age (CA) on 180 extremely preterm infants [EPIs] (24 0/7-26 6/7 GA and 27 0/7 - 28 6/7 GA) enrolled at three neonatal intensive care units: Catholic Health Initiative (CHI) Health St. Elizabeth (Lincoln, NE), Tufts Medical Center (Boston, MA), and Santa Clara Valley Medical Center (San Jose, CA). EPIs will be randomized to a blind pacifier (SHAM) or PULSED NTrainer treatment groups, and stratified by GA, sex, and bronchopulmonary dysplasia status (BPD vs non-BPD). We hypothesize that the combination of the NTrainer® intervention for improved oral feeding skills, along with objective salivary gene expression data to monitor response to treatment and feeding development, will result in a novel, objective, and personalized approach to neonatal oral feeding and reduce the duration of time to attain oral feeds while improving feeding, growth and neurodevelopmental outcomes at 18 months' CA.
Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific total bilirubin level and need for intervention has been elusive. This is most likely due to other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy has impacted clinical and family-centered care, and in the extreme preterm infants, it may have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy in in order to reduce its use is unique. The investigators have assembled a transdisciplinary team to examine critical unanswered questions including the role of bilirubin binding capacity (BBC) of an individual during the first week of life in the context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that includes neuro-anatomical, hearing, visual and developmental processing impairments. In this study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin load for the first time in the context of a clinical decision algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that knowledge gained from this study will lead to ethically testable hypotheses to individualize the prescription of phototherapy.
This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample. Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program. Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months. The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.
While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings. The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.
Background: Maternal and child under-nutrition is the underlying cause of death for millions across the globe. Anemia during pregnancy is among the leading nutritional disorders with serious short and long term consequences to both the mother and fetus. Objective: Examine the effect of dietary diversity on maternal anemia, nutritional status and key pregnancy outcomes of pregnancy. Methods: A prospective cohort study design, involving a total of 432 eligible pregnant women, in their second antenatal care visit was conducted between August 2014 to March, 2015. The individual dietary diversity Score (IDDS) was used as the exposure variable to select, enroll and follow the mothers. Epi-data, SPSS and STATA software are used to enter and analyze the data. Chi-square test, independent 't'-test, and GLM are used to calculate risk, association and differences between key variables at P < 0.05
The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.
The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).