Rehabilitation of Malnourished Infants With F-100 or Diluted F-100
Rehabilitation of Severely Malnourished Infants Aged <6months: a Randomised, Controlled Comparison of Three Recovery Diets (Infant Formula, F-100 and Diluted F-100)
1 other identifier
interventional
132
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 28, 2015
June 1, 2015
3.4 years
March 5, 2012
July 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of weight gain (g/kg/d)
Duration of the hospital stay when the study participants will fulfill the discharge criteria. On an average of 2 weeks.
Study Arms (3)
Infant Formula
ACTIVE COMPARATORA diet that is being fed to the young infants
F-100
EXPERIMENTAL• 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
Diluted F-100
EXPERIMENTAL300 ml of water is added to 1000 ml of F-100
Interventions
• 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
Eligibility Criteria
You may qualify if:
- They have a weight-for-length deficit of \<-3SD and/or bi-pedal oedema on admission
- They are less than 6 months old and have completed the initial stabilization phase
- They are stabilized in less than 9 days (to exclude children who fail to respond to treatment)
- Parental consent is obtained for enrollment in the study.
You may not qualify if:
- Infants with congenital anomalies such as, congenital cardiac defects, cleft lip or palate or any other condition that interfering with feeding, chromosomal anomalies, and other organic problems including jaundice, tuberculosis etc. will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICDDR,B
Dhaka, Mohakhali, Dhaka Division, 1212, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Md. Munirul Islam, MBBS, PhD
Associate Scientist
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2012
First Posted
March 20, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 28, 2015
Record last verified: 2015-06