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F-75 vs undiluted milk for severely malnourished infants

Undiluted animal milk with added sugar and micronutrients versus WHO feeding protocol for management of severe acute malnutrition in non-breastfed infants aged 2-6 months of age: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003196
Enrollment
320
Registered
2012-12-07
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: Undiluted toned milk with added sugar: 8 g of sugar added to 200 mL toned milk, given 130 mL/kg/day in 2 hourly schedule initially, and changed as per WHO feeding protocol. Duration of

Sponsors

Department of Biotechnology Ministry of Science Technology Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All severely malnourished non-breastfed infants aged 2 to 6 months of age (defined as weight for length < -3 SD of WHO Growth standards6 and/or bilateral pedal edema), with no prospect for breastfeeding shall be enrolled.

Exclusion criteria

Exclusion criteria: 1. Edematous malnutrition 2. Children with persistent diarrhea. 3. Very severe pneumonia (as defined by WHO) 4. Breastfed or partially breastfed infants 5. Congenital heart disease 6. Major congenital anomalies (e.g congenital renal anomalies, congenital hydrocephalus) 7. Infants not fit for enteral nutrition, e.g paralytic ileus, gastrointestinal bleeding, septic shock. 8. Infants born to HIV positive mothers. 9. Infants with hypernatremia (serum sodium >150 mEq/L) at admission.

Design outcomes

Primary

MeasureTime frame
1)Time taken in days to achieve 15% weight gain 2)Time taken to achieve stabilization [normal appetite (easily finishes 4 hourly feeds), no hypoglycemia, no hypothermia, no shock, less than 5 stools/day, no vomiting] Timepoint: till discharge—

Secondary

MeasureTime frame
Average weight gain (g/kg/d) during first 3 months. Timepoint: 3 months;Duration of hospital stay Timepoint: till discharge;Incidence of hypernatremia , azotemia during hospital stay and follow-up. Timepoint: 3 months;Incidence of hypocalcemia and hyperphosphatemia during hospital stay and follow-up. Timepoint: 3 months;Mortality during hospital stay and follow-up period till 3 months. Timepoint: 3 months;Number of days of diarrhea (from enrolment till last abnormal stool). The last abnormal stool will be defined when it is followed by passage of normal stool or no stool in next 24 hours.Timepoint: 3 months—

Countries

India

Contacts

Public ContactProf Satinder Aneja

LHMC

drsaneja@gmail.com

Outcome results

None listed

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