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NCT ID: NCT01258647 Completed - Malnutrition Clinical Trials

Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars

CAT01
Start date: October 2010
Phase: N/A
Study type: Interventional

Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micronutrients. Although supplementation with selected micronutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.

NCT ID: NCT01084109 Completed - Clinical trials for Complementary Feeding

First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial

First Bites
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.

NCT ID: NCT00906880 Completed - Clinical trials for Human African Trypanosomiasis

Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase

NECT-FIELD
Start date: April 2009
Phase: Phase 4
Study type: Interventional

Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase. Overall objectives: Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers). Primary objective: - Assess the clinical response of the NECT co-administration under field conditions. Secondary objectives: - Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these. - Assess the feasibility of the implementation of the NECT coadministration by the health center. - Assess the effectiveness of the NECT co-administration at 24* months after treatment.

NCT ID: NCT00819858 Completed - Malaria Clinical Trials

Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight

Start date: January 2009
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.

NCT ID: NCT00803933 Completed - Clinical trials for African Trypanosomiasis

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

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

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control. This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.

NCT ID: NCT00802594 Completed - Clinical trials for Trypanosomiasis, African

A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Start date: August 2001
Phase: Phase 2
Study type: Interventional

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs which might be used as a tool to support disease control that is easily administered and has low toxicity. This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of more than a dozen partners from academia, industry, and the Ministries of Health of Angola and the Democratic Republic of Congo.

NCT ID: NCT00640055 Completed - Perinatal Mortality Clinical Trials

Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

VA
Start date: July 2007
Phase: Phase 4
Study type: Interventional

The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH trial is an ongoing study of neonatal resuscitation training in rural community settings within Global Network sites in Central Africa, Asia and Latin America. This study uses a validated VA questionnaire to determine COD of stillbirths and early neonatal deaths among participants in the FIRST BREATH study. We propose to expand the usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether the Community Coordinator (a non-physician health worker) can assign COD with a high level of concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth Attendant can provide as reliable perinatal information as the mother during the VA interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70% of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.

NCT ID: NCT00146627 Completed - Clinical trials for Trypanosomiasis, African

Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

Start date: n/a
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) in the meningoencephalitic phase.

NCT ID: NCT00136708 Completed - Asphyxia Neonatorum Clinical Trials

First Breath: Neonatal Resuscitation in Developing Countries

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

In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

NCT ID: NCT00121368 Completed - Smoking Clinical Trials

GN Tobacco Use Survey

Start date: February 2004
Phase: N/A
Study type: Observational

Smoking can contribute to many health problems for mothers and their babies. In developing countries, there is little information about the number of pregnant women that smoke and the reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.