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NCT ID: NCT00625482 Completed - Mortality Clinical Trials

Sex-Differential Health Interventions In Low-Birth-Weight Infants

Start date: February 2008
Phase: N/A
Study type: Interventional

Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS). Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial. We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.

NCT ID: NCT00527774 Completed - Quality of Life Clinical Trials

Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients

Start date: September 2007
Phase: N/A
Study type: Observational

The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine characteristics that can be linked to poor clinical outcome and to examine the hypothesis that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization, cardiovascular and all-cause mortality.

NCT ID: NCT00518856 Completed - Mortality Clinical Trials

Lufwanyama Neonatal Survival Project

LUNESP
Start date: September 2006
Phase: N/A
Study type: Interventional

We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.

NCT ID: NCT00514891 Terminated - Mortality Clinical Trials

Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts

Start date: August 2007
Phase: Phase 4
Study type: Interventional

High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%. The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of age. However, the effect of providing VAS with vaccines has never been investigated. We have hypothesised that the effect of VAS depends on the immune stimulus at the time of supplementation. Hence, the effect might vary depending on which type of vaccine it is given with. In particular, we hypothesised that VAS might be beneficial when given with measles vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age would be a measles vaccine, but many children come late for their DTP vaccinations and receive DTP alone or together with measles vaccine. Hence, it is important to study whether the effect of VAS is the same irrespective of the vaccine(s) administered at the same time. Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines, but plans to do so within the next years. Together with the Ministry of Health in Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This will be done in a large randomised trial. BHP has a demographic surveillance system (DSS) which has followed a population of now more than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age, and will be followed through the DSS to assess mortality and morbidity. Based on previous observations, the effects of VAS might differ according to sex and season. The interaction between VAS, sex, and season will also be studied in the present trial. By identifying situations where VAS may be beneficial, ineffective, or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries.

NCT ID: NCT00474981 Completed - Mortality Clinical Trials

Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality

IMNCI-India
Start date: June 2006
Phase: N/A
Study type: Interventional

This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000. The IMNCI intervention includes three main components: 1. improvement in the case management skills of health staff 2. improvement in the overall health system to support its performance, and 3. improvement in family and community health care practices which include: - prevention and management of hypothermia - early initiation of breastfeeding and exclusive breastfeeding - community-based care of low birth weight infants - improved care-seeking for neonatal infections The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes. The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography. The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.

NCT ID: NCT00465777 Completed - Malaria Clinical Trials

Improved Management and in-Hospital Mortality

MTV
Start date: December 2004
Phase: N/A
Study type: Interventional

The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

NCT ID: NCT00429000 Not yet recruiting - Hypothermia Clinical Trials

Perinatal Hypothermia, Risk Factors and Long-Term Consequences in Guinea-Bissau, Westafrica

Start date: January 2007
Phase: N/A
Study type: Interventional

Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased mortality rate, which persist at least two months after birth. Therefore interventions that reduce the prevalence of HT might have a significant effect on infant mortality. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.

NCT ID: NCT00390624 Completed - Mortality Clinical Trials

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Start date: July 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is to combine Urodilatin (ANP analogue), which will increase glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase II study comparing results with historical controls. We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic bone marrow transplantation can be significantly reduced by the use of protective agents Urodilatin and mannitol. We feel that this combination is best administered prior to and during the first two weeks of treatment when patients encounter immunosuppressive agents and the onset of early transplantation complications.

NCT ID: NCT00278746 Completed - Diarrhea Clinical Trials

Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

Start date: January 2005
Phase: N/A
Study type: Interventional

Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.

NCT ID: NCT00269542 Completed - Pneumonia Clinical Trials

Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

Start date: February 2002
Phase: N/A
Study type: Interventional

Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.