Growth pattern in Very low birth weight babies of weight 1000-1500 grams on different feeding regimens(example: Breast Milk alone , Breast milk with small amount of formula feeds, Breast milk with fortifier)
Not Applicable
- Conditions
- Health Condition 1: P071- Other low birth weight newborn
- Registration Number
- CTRI/2021/04/032636
- Lead Sponsor
- Intramural
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Neonates of 1000-1500 grams
2.Appropriate for age(AGA)
3.Gestational age of 28-32 weeks
Exclusion Criteria
1.Small for gestation(SGA)
2.Refusal of consent
3.Neonates not initiated on enteral feeds with 72 hours
4.Neonates with suspecting genetic disorders/congenital anomalies
5.TORCH infection
6.Any baby requiring iv fluids for greater than one week
7. APGAR less than 5 at 5minutes of birth
8. Reversed end-diastolic flow in umbilical artery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary objectives <br/ ><br>1.Assessing the growth pattern and catch-up growth of preterm ,VLBW, appropriate for gestational age infants(less than 1500 grams) on two different feeding regimes <br/ ><br>2.Analysing the cost effectiveness of the intervention <br/ ><br> <br/ ><br>Timepoint: Growth of babies will be monitored every weekly and will be documented from 2nd week onwards every weekly till discharge or until baby reaches target weight of 1800 grams whichever is earlier. In case of earlier discharge of babies before reaching 1800 grams that babies will be followed up <br/ ><br> <br/ ><br>Withdrawal criteria: Child will be excluded from study if child did not gain minimum weight of 10 grams /day over 3 days during monitoring <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary objective <br/ ><br>1.Duration of hospital stay <br/ ><br>2.Incidence of feeding problems, Neonatal hyperbilurubinemia and duration , Necrotising enterocolitis(NEC) ,Sepsis ,Severity of Retinopathy of prematurity(ROP) ,Anemia of prematurity, Osteopenia of prematurity, requirement of non-invasive ventilation(NIV) <br/ ><br> <br/ ><br>Timepoint: If babies require non-invasive ventilation/feeding intolerance/sepsis/hyper bilirubinemia will be documented <br/ ><br>Withdrawal criteria: Child will be excluded from study if child did not gain minimum weight of 10grams /day over 3 days during monitoring <br/ ><br>Calcium, phosphorus, ALP are done at discharge. Hemoglobin will be done based on clinical picture of infant <br/ ><br>