Community-based Follow-up of Severely Malnourished Children

NCT01157741 | Completed Phase 2 DMC

• 1 other identifier: 2003-033
• Study Type: interventional
• Target: 507
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 3.All management like intervention A at CNFU + supplementary food (SF) for the first 3 months (intervention B).
4. 4.All management like intervention A at CNFU + psychosocial stimulation (PS) for the first 3 months (intervention C).
5. 5.All management like intervention A at CNFU + SF + PS for the first 3 months (intervention D).

Conditions

Malnourished Children

Keywords

Community based follow up, severely underweight children

Outcome Measures

Primary Outcomes (2)

• Rate of follow up

  Up to 3 months of intervention

• Rate of weight gain

  after 3 months of intervention

Secondary Outcomes (2)

• Changes in urinary Lactulose: Mannitol (ratio)

  By the end of 3 months

• Changes in development index

  Changes over 6 months

Study Arms (5)

Standard Practice (H-C)

NO INTERVENTION

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

C-C

EXPERIMENTAL

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

C-SF

EXPERIMENTAL

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)

C-PS

EXPERIMENTAL

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)

C-SF+PS

EXPERIMENTAL

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

Interventions

C-C BEHAVIORAL

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

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

Standard Practice (H-C)

C-SF OTHER

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

Also known as: As C-C but with additional supplementary food (SF) (C-SF)

C-C

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

Giving psychosocial stimulation

C-SF

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

Giving both SF \& PS

C-PS

H-C OTHER

Follow-up at Hospital

C-SF+PS

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Persistent anorexia, fever, severe wasting (WH \< -3 Z score) or edema
• Clinically apparent congenital/acquired disorders that may affect growth
• Other acute or chronic diseases requiring hospitalization and/or affecting growth
• Lack of fixed address (to avoid difficulties in tracing for follow up examinations)
• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of California, Davis: collaborator

Related Publications (1)

• Hossain MI, Nahar B, Hamadani JD, Ahmed T, Brown KH. Effects of community-based follow-up care in managing severely underweight children. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):310-9. doi: 10.1097/MPG.0b013e31821dca49.

  PMID: 21505367 DERIVED

Study Officials

• Md Iqbal Hossain, Phd

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: October 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 8, 2010

Record last verified: 2003-12