Active clinical trials for "Asphyxia Neonatorum"

Melghat is poorly developed tribal area in India with very high child mortality & malnutrition prevalence (grossly inadequate medical facilities). Important health problems. Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W. babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing government ICDS and health system. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages.

Introduction Birth asphyxia is one of leading causes of neonatal mortality in Uganda. It is associated with long term neuro-developmental complications among the babies that survive. Preventive measures for birth asphyxia intrauterine are not clearly understood and thus the need for this study. The aim of the study is to assess the effect of intrapartum oxygen administration on fetal and early neonatal outcomes. Methods A double-blind randomized clinical trial which will be conducted in Gulu regional referral and Kawempe National referral hospitals in Uganda. A total sample size of 1108 women in labour will be enrolled with 554 participants per group. The intervention will include administration of 10 L/min of 100% oxygen for 15 minutes to women in established labor who have signs of fetal distress with fetal heart rate of less than 120 or above 160 beats per minute. The control group will receive medical air (21% oxygen) using the same criteria. Women and babies will be followed up until 7 days after birth to document the outcomes. Statistical analysis to identify difference in outcomes between the control and intervention groups will be performed. Ethical considerations Ethical approval and permission was received from relevant research and ethics committees. Informed consent will be sought from the participants. A data and safety monitoring board will be set up to review periodically the progress of the clinical trial study. Participants will be monitored for adverse events and severe adverse events; reporting will be done according to the research and ethics committee guidelines.

Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.

This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application ("HBB Prompt") to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.

This study evaluates the impact of a longitudinal remote consultation (LRC) implementation strategy for collaborative care depression treatment among perinatal women. All participating health centers will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select health centers. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.

An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.

The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia. It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age. After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags. Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors. Participant files will be stored for a period of 10 years after completion of the study. All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.

The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.