Rehabilitation of Malnourished Infants With F-100 or Diluted F-100

Summary

Hypothesis:

During rehabilitation phase of management of severe acute malnourished Bangladeshi infants less than 6 months old, rates of weight gain will be significantly more in children fed F-100 and diluted F-100 compared to those fed infant formula.

Brief summary:

Until recently, severe malnutrition has been relatively rare in infants younger than 6 months, but with urbanization and the HIV/AIDS pandemic it is feared that the incidence of severe malnutrition among young infants will rise. The question of how best to feed infants aged \<6 months has thus come to the forefront. Given the lack of published evidence regarding the most advantageous formulations for feeding severely malnourished infants aged \<6 months, there is a need for observational studies and comparative randomized trials of alternative formulations to guide decisions about optimum dietary management in this age group. This area has been aptly considered a research priority during the consultation meeting of experts from all over the world convened by the World Health Organization on management of severe malnutrition in September 2004.

In the WHO case-management guidelines for severe malnutrition, there is no separate provision for young infants (infants less than 6 months old). The guidelines suggest the use of a low-solute formula (F-75) and continued breastfeeding in the initial stabilisation phase. In the rehabilitation phase, the guidelines advise F-100 with an energy density of 100kcal/100ml to promote catch-up growth. There is a concern that the renal solute load from using F-100 is too high for young infants, and some groups have started using diluted F-100 with an energy density of 75 kcal/100 ml.

Another related issue is the contribution of breastfeeding in dietary intakes during rehabilitation. In severely malnourished infants, breast milk intakes are likely to be low initially when appetite is poor, but may be substantial as the infant recovers. Uncertainty about breast milk intakes has led to conflicting opinions and advice, weaning from the breast as it is not providing sufficient energy (1).

The aim of this study, to be conducted in a carefully supervised Nutrition Rehabilitation Unit (NRU), will compare three recovery diets (Infant formula, F-100 and diluted F-100) in order to provide the evidence-base to determine if a change or add-on in terms of diet in the WHO guidelines is needed. It will also measure the potential renal solute load (mosmol/l), serum electrolytes and plasma osmolality of the same children. Body composition of the infants will also be measured using stable isotope dilution technique before and after the intervention diet is provided.

Conditions

• Severely Malnourished Infants Who Are Less Than 6 Months Old

Interventions

DIETARY_SUPPLEMENT

Infant Formula

A diet that is being fed to the young infants.

DIETARY_SUPPLEMENT

F-100

• F-100: The estimated PRSL for F-100 is 360 mOsm/L or 53 mOsm/100kcal and in a young infant growing normally this could exceed the excretory capacity of the kidney with the risk of hypernatremic dehydration. In the rehabilitation phase, however, severely malnourished children grow extremely rapidly and the potential solutes (e.g. protein, potassium) are deposited in lean tissue and do not present to the kidney for excretion. Thus, although the potential RSL is high, this has been assumed to be a theoretical risk for rapidly growing infants

DIETARY_SUPPLEMENT

Diluted F-100

300 ml of water is added to 1000 ml of f-100

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Principal Investigators

• Md. Munirul Islam, MBBS, PhD · Associate Scientist

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Bangladesh

Study Locations