Community-based Follow-up of Severely Malnourished Children
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|ClinicalTrials.gov Identifier: NCT01157741|
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 8, 2010
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:
- 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).
- All management like control group, but follow up at community-based nutrition follow-up unit (CNFU) (fortnightly for 1st 3 months) (intervention A).
- All management like intervention A at CNFU + supplementary food (SF) for the first 3 months (intervention B).
- All management like intervention A at CNFU + psychosocial stimulation (PS) for the first 3 months (intervention C).
- 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 or disease||Intervention/treatment||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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||507 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (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|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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.
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
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.
As C-C but with additional supplementary food (SF) (C-SF)
Other Name: As C-C but with additional supplementary food (SF) (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
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
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.
Follow-up at Hospital
- Rate of follow up [ Time Frame: Up to 3 months of intervention ]
- Rate of weight gain [ Time Frame: after 3 months of intervention ]
- Changes in urinary Lactulose: Mannitol (ratio) [ Time Frame: By the end of 3 months ]
- Changes in development index [ Time Frame: Changes over 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157741
|Principal Investigator:||Md Iqbal Hossain, Phd||International Centre for Diarrhoeal Disease Research, Bangladesh|