F-75 vs undiluted milk for severely malnourished infants
Not Applicable
- Conditions
- Health Condition 1: null- Severe malnutrition
- Registration Number
- CTRI/2012/12/003196
- Lead Sponsor
- Department of Biotechnology Ministry of Science Technology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 320
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Time taken in days to achieve 15% weight gain <br/ ><br>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] <br/ ><br>Timepoint: till discharge
- Secondary Outcome Measures
Name Time Method Average weight gain (g/kg/d) during first 3 months. <br/ ><br>Timepoint: 3 months;Duration of hospital stay <br/ ><br>Timepoint: till discharge;Incidence of hypernatremia , azotemia during hospital stay and follow-up. <br/ ><br> <br/ ><br>Timepoint: 3 months;Incidence of hypocalcemia and hyperphosphatemia during hospital stay and follow-up. <br/ ><br>Timepoint: 3 months;Mortality during hospital stay and follow-up period till 3 months. <br/ ><br>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