Community-based Follow-up of Severely Malnourished Children

NCT01157741 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2010-07-08

No results posted yet for this study

Summary

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.

Conditions

  • Malnourished Children

Interventions

BEHAVIORAL

C-C

Mx as H-C plus positioning follow up in the community clinic

OTHER

C-SF

As C-C but with additional supplementary food (SF) (C-SF)

OTHER

As C-C with additional psychosocial stimulation (PS) (C-PS)

Giving psychosocial stimulation

OTHER

As C-C but with both SF & PS (C-SF+PS)

Giving both SF \& PS

OTHER

H-C

Follow-up at Hospital

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Md Iqbal Hossain, Phd · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01157741 on ClinicalTrials.gov