Trial record 12 of 90 for:    Open Studies | infant AND nutrition

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01558440
First received: March 5, 2012
Last updated: March 13, 2014
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Severely Malnourished Infants Who Are Less Than 6 Months Old
Dietary Supplement: Infant Formula
Dietary Supplement: F-100
Dietary Supplement: Diluted F-100
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitation of Severely Malnourished Infants Aged <6months: a Randomised, Controlled Comparison of Three Recovery Diets (Infant Formula, F-100 and Diluted F-100)

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • rate of weight gain (g/kg/d) [ Time Frame: Duration of the hospital stay when the study participants will fulfill the discharge criteria. On an average of 2 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infant Formula
A diet that is being fed to the young infants
Dietary Supplement: Infant Formula
A diet that is being fed to the young infants.
Experimental: 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: 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
Experimental: Diluted F-100
300 ml of water is added to 1000 ml of F-100
Dietary Supplement: Diluted F-100
300 ml of water is added to 1000 ml of f-100

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558440

Contacts
Contact: M. A. Salam Khan +880 2 984 0523-32 ext 3206 salamk@icddrb.org

Locations
Bangladesh
ICDDR,B Recruiting
Dhaka, Mohakhali, Dhaka, Bangladesh, 1212
Contact: M A Salam Khan    +880 2 984 0523-32 ext 3206    salamk@icddrb.org   
Principal Investigator: Md. Muniurl Islam, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Md. Munirul Islam, MBBS, PhD Associate Scientist
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01558440     History of Changes
Other Study ID Numbers: PR-10039
Study First Received: March 5, 2012
Last Updated: March 13, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Nutrition rehabilitation
severe malnutrition
infant formula
F-100

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on September 16, 2014