A clinical trial to study the effect of enriching expressed human milk with additional protein on growth of very low birth weight newborns (babies with birth weight less than 1500 grams).
- Conditions
- Health Condition 1: null- GROWTH OF VERY LOW BIRTH WEIGHT NEWBORNS
- Registration Number
- CTRI/2014/01/004279
- Lead Sponsor
- The Institute of Post Graduate Medical Education Research IPGMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 72
a. Babies with birth weight between 800-1500 gram admitted in SSKM NICU during the study period.
b. Parents of the babies must give informed consent in writing
a. All babies with major congenital anomalies will be excluded.
b. Severe gastrointestinal malformations such as Gastroschisis, Omphalocele,Tracheo-EsophagealFistulaor surgical conditions affecting the gastrointestinal tract such as intussusceptions, volvulus, malrotation, meconium ileus etc. or necrotizing enterocolitis .
c. Babies being kept NPO for 3consecutive days or kept at a reduced feeding for 5 days, babies having radiological proven NEC and those babies having bloody stool will be excluded from the study.
d. Those babies discharged before their growthcould be monitored for at least a period of 14 days will be excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. weight gain(gram/kg/day) <br/ ><br>2. increase in length (cm/week) <br/ ><br>3. increase in head circumference (cm/week)Timepoint: at the end of week 1,week 2, week 3 and week 4 of the study
- Secondary Outcome Measures
Name Time Method 1. pH and base deficit of the blood <br/ ><br>2. Serum BUN <br/ ><br>3. serum Creatinine <br/ ><br>4. incidence of necrotising enterocolitis and feeding intoleranceTimepoint: at the end of week 1,week 2, week 3 and week 4 of the study