Community-based Follow-up of Severely Malnourished Children

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01157741
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: December 2003
  Purpose

Improved methods of community/home management and follow-up of severely undernourished children need to be developed in low-income countries like Bangladesh. The proposed study will be conducted at ICDDR,B Hospital and in different urban primary health care centres within Dhaka city. The efficacy of four different interventions will be evaluated/compared with control with respect to the rate of completion of clinical follow-up and growth, morbidity, and changes in psychomotor development in 500 children aged 6-24 months presenting to ICDDR,B with initial weight-for-age (WA) <-3 Z score. The interventions are:

  1. Usual follow-up (fortnightly for 1st 3 months) service at the hospital nutrition follow-up unit (HNFU) including growth monitoring and promotion + health education + micronutrient supplementation and treatment of intercurrent illness (current standard practice; control group).
  2. All management like control group, but follow up at community-based nutrition follow-up unit (CNFU) (fortnightly for 1st 3 months) (intervention A).
  3. All management like intervention A at CNFU + supplementary food (SF) for the first 3 months (intervention B).
  4. All management like intervention A at CNFU + psychosocial stimulation (PS) for the first 3 months (intervention C).
  5. All management like intervention A at CNFU + SF + PS for the first 3 months (intervention D).

After the initial three months intervention period, children in all groups will be followed on fortnightly basis for next three months in their respective follow up unit.

Follow-up rate, nutritional status, mental and psychomotor development, behavior, morbidities (including intestinal permeability in a sub-sample) of the children, and child rearing practices, depression and self esteem of mothers will be assessed in different groups.

By ascertaining the most cost-effective/best management package, and by extending the package to other systems in the country, it will be possible to rehabilitate a greater number of severely malnourished children in their communities.


Condition Intervention Phase
Malnourished Children
Behavioral: C-C
Other: C-SF
Other: As C-C with additional psychosocial stimulation (PS) (C-PS)
Other: As C-C but with both SF & PS (C-SF+PS)
Other: H-C
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of Community-based Follow-up, Food Supplementation and Psychosocial Stimulation in the Home-management of Young Severely Malnourished Bangladeshi Children: a Randomized Intervention Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of follow up [ Time Frame: Up to 3 months of intervention ] [ Designated as safety issue: Yes ]
  • Rate of weight gain [ Time Frame: after 3 months of intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in urinary Lactulose: Mannitol (ratio) [ Time Frame: By the end of 3 months ] [ Designated as safety issue: Yes ]
  • Changes in development index [ Time Frame: Changes over 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 507
Study Start Date: October 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Practice (H-C)
1) Hospital control group (Group H-C): children assigned to this group received the standard hospital-based, outpatient treatment package, which consisted of fortnightly follow-up for growth monitoring, health and nutrition education, and micronutrient supplementation.
Behavioral: C-C
Mx as H-C plus positioning follow up in the community clinic
Other Name: Mx as H-C plus positioning follow up in the community clinic
Experimental: C-C
Community-based follow-up (Group C-C): the standard community-based follow-up package was identical to the one provided to the hospital-based control group, except that the follow-up visits took place at the nearest CNFU rather than the HNFU.
Other: C-SF
As C-C but with additional supplementary food (SF) (C-SF)
Other Name: As C-C but with additional supplementary food (SF) (C-SF)
Experimental: C-SF
Community-based follow-up plus supplementary food (Group C-SF): children assigned to this group received the same treatment package as those in Group C-C, except that supplementary food (SF) packets and preparation instructions were also provided at the time of each follow-up clinic visit for consumption at home in addition to the children's usual meals.
Other: As C-C with additional psychosocial stimulation (PS) (C-PS)
Giving psychosocial stimulation
Experimental: C-PS
Community-based follow-up plus psychosocial stimulation (Group C-PS): children assigned to this group received the same treatment package as those in Group C-C, except that they were also provided with psychosocial stimulation (PS).
Other: As C-C but with both SF & PS (C-SF+PS)
Giving both SF & PS
Experimental: C-SF+PS
Community-based follow-up plus SF and PS (Group C-SF+PS): children assigned to this group received the same treatment package as those in the Group C-C, except that they were also provided with both SF and PS, as described above.
Other: H-C
Follow-up at Hospital

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 6 - 24 months
  2. Either sex
  3. Severely malnourished [weight for age (WA) < -3 Z score]
  4. Resolution of acute illnesses
  5. Not planning to leave the current residence within next six months (for the purpose of follow-up)
  6. Informed consent granted from the guardian.

Exclusion Criteria:

  1. Persistent anorexia, fever, severe wasting (WH < -3 Z score) or edema
  2. Clinically apparent congenital/acquired disorders that may affect growth
  3. Other acute or chronic diseases requiring hospitalization and/or affecting growth
  4. Lack of fixed address (to avoid difficulties in tracing for follow up examinations)
  5. Caregiver's condition: children accompanied by caregivers who are not able to give any time for child care or unable to give stimulation due to any condition e.g. old age, disease, physical or mental handicap.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01157741

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of California, Davis
Investigators
Principal Investigator: Md Iqbal Hossain, Phd International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Md Iqbal Hossain, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01157741     History of Changes
Other Study ID Numbers: 2003-033
Study First Received: July 6, 2010
Last Updated: July 7, 2010
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Community based follow up, severely underweight children

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on August 28, 2014