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A clinical trial to study the efficacy of whole milk feeding during initial management of severely malnourished children

Comparison of Whole Milk and WHO F-75 Feeding Formula during Early Stabilization of Severely Malnourished Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001853
Enrollment
60
Registered
2011-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Severe Malnutrition

Interventions

Intervention1: whole milk (toned): the dose and frequency of milk will be according to the WHO guidelines for feeding during first week in cases of severe malnutrition. Control Intervention1: whole mi

Sponsors

University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: severe malnutrition (weight for length 3 standard deviation as per WHO growth standards)

Exclusion criteria

Exclusion criteria: 1. Children having clinical evidence of any chronic disease (e.g. cerebral palsy, congenital heart diseases, hemolytic anemia, malignancies, known metabolic disorders, known malabsorption syndromes, chromosomal malformations, chronic renal disorders) as a cause of severe malnutrition. 2. Very sick children such as those on ventilator, having refractory shock or gastrointestinal bleeding. 3. Children with persistent diarrhea (acute onset diarrhea of duration 14 days).

Design outcomes

Primary

MeasureTime frame
1) Weight change (g/kg/day) during first week of treatment. 2)Duration for appetite to return to normal .(child easily finishes 4 hourly feeds) 3)Treatment failure. Timepoint: 7 days

Secondary

MeasureTime frame
1) Amount of feed consumed and retained (mL/kg/day) during first week. 2) Number of episodes of vomiting. 3) Duration of diarrhea after initiation of therapy (in those presenting with diarrhea) 4) Duration of hospital stay. 5) Mortality. Timepoint: 7 days

Countries

India

Contacts

Public ContactDr Dheeraj Shah

Department of Pediatrics, University College of Medical Sciences and GTB Hospital

shahdheeraj@hotmail.com09868399792

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026