Zambia Exclusive Breastfeeding Study

02:55 EDT 27th March 2015 | BioPortfolio


The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.


It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings, where the HIV epidemic now predominates, breast feeding cannot simply be replaced by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infant feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource setting.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


HIV Infection


Abrupt weaning at 4 months of age


George and Chawama District Health Clinics


Active, not recruiting


Boston Medical Center

Results (where available)

View Results


Clinical Trials [216 Associated Clinical Trials listed on BioPortfolio]

B-type Natriuretic Peptide for the Management of Weaning

Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit (ICU) patients may be improved by minimizing the positive fluid balance. In particula...

Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.

Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients

Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguate...

Does Deflating the Tracheal Cuff Shorten Weaning Time?

The purpose of this study is to determine whether deflating the tracheal cuff in tracheostomized patients, during disconnections from ventilatory support along the weaning phase shortens t...

Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients

This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protoco...

PubMed Articles [11659 Associated PubMed Articles listed on BioPortfolio]

Effects of starting weaning exclusively with vegetables on vegetable intake at the age of 12 and 23 months.

The low vegetable intake in children may be attributed to their low preference for vegetables. During the first year of life, first taste preferences are formed, which may track over time. In a previo...

Quantitative correlation of aflatoxin biomarker with dietary intake of aflatoxin in Tanzanian children.

Abstract The association between aflatoxin intake from maize-based weaning food and aflatoxin albumin adducts (AF-alb) was investigated in 148 Tanzanian children aged between 12 and 22 months, at 2 vi...

Automated weaning and SBT systems versus non-automated weaning strategies for weaning time in invasively ventilated critically ill adults.

Automated systems use closed-loop control to enable ventilators to perform basic and advanced functions while supporting respiration. SmartCare™ is a unique automated weaning system that measures se...

Weaning children off enteral nutrition by netcoaching versus onsite treatment: A comparative study.

The Graz model of tube weaning has been internationally recognised as a successful and rapid tube weaning program. Beside the onsite treatment option, a telemedical counselling was specifically develo...

Ventilatory weaning practices in intensive care units in the city of Cali.

Objective: Early weaning from mechanical ventilation is one of the primary goals in managing critically ill patients. There are various techniques and measurement parameters for such weaning. The obje...

Medical and Biotech [MESH] Definitions

Techniques for effecting the transition of the respiratory-failure patient from mechanical ventilation to spontaneous ventilation, while meeting the criteria that tidal volume be above a given threshold (greater than 5 ml/kg), respiratory frequency be below a given count (less than 30 breaths/min), and oxygen partial pressure be above a given threshold (PaO2 greater than 50mm Hg). Weaning studies focus on finding methods to monitor and predict the outcome of mechanical ventilator weaning as well as finding ventilatory support techniques which will facilitate successful weaning. Present methods include intermittent mandatory ventilation, intermittent positive pressure ventilation, and mandatory minute volume ventilation.

ENDOCARDIUM infection that is usually caused by STREPTOCOCCUS. Subacute infective endocarditis evolves over weeks and months with modest toxicity and rare metastatic infection.

A fungal infection that may appear in two forms: 1, a primary lesion characterized by the formation of a small cutaneous nodule and small nodules along the lymphatics that may heal within several months; and 2, chronic granulomatous lesions characterized by thick crusts, warty growths, and unusual vascularity and infection in the middle or upper lobes of the lung.

Chronic endemic respiratory disease of dairy calves and an important component of bovine respiratory disease complex. It primarily affects calves up to six months of age and the etiology is multifactorial. Stress plus a primary viral infection is followed by a secondary bacterial infection. The latter is most commonly associated with PASTEURELLA MULTOCIDA producing a purulent BRONCHOPNEUMONIA. Sometimes present are MANNHEIMIA HAEMOLYTICA; HAEMOPHILUS SOMNUS and mycoplasma species.

Any observable response or action of a child from 24 months through 12 years of age. For neonates or children younger than 24 months, INFANT BEHAVIOR is available.

More From BioPortfolio on "Zambia Exclusive Breastfeeding Study"

Search BioPortfolio:

Relevant Topics

The top 5 most promising drugs (February 2014)
Latest News Clinical Trials Research Drugs Reports Corporate
THE FIVE MOST PROMISING DRUGS LAUNCHED OR RECEIVING APPROVAL February 2014 Drug Disease Company Gazyva™ Chronic lymphocytic leukemia Biogen Idec/Genentech/ F. Hoffman-La Roche ...

Latest News Clinical Trials Research Drugs Reports Corporate
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial