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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)

Growth pattern and catchup growth of Very Low Birth Weight Infants on different feeding regimes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032636
Enrollment
120
Registered
2021-04-07
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: P071- Other low birth weight newborn

Interventions

Intervention1: Addition of human milk fortifier and preterm formula for VLBW babies to look for growth pattern: â?¢ Hemodynamically stable preterm infants were initiated with expressed breast milk at

Sponsors

Intramural
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates of 1000-1500 grams 2.Appropriate for age(AGA) 3.Gestational age of 28-32 weeks

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
primary objectives 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 2. Analysing the cost effectiveness of the intervention 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 Withdrawal criteria: Child will be excluded from study if child did not gain minimum weight of 10 grams /day over 3 days during monitoring—

Secondary

MeasureTime frame
Secondary objective 1. Duration of hospital stay 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) Timepoint: If babies require non-invasive ventilation/feeding intolerance/sepsis/hyper bilirubinemia will be documented Withdrawal criteria: Child will be excluded from study if child did not gain minimum weight of 10grams /day over 3 days during monitoring Calcium, phosphorus, ALP are done at discharge. Hemoglobin will be done based on clinical picture of infant—

Countries

India

Contacts

Public ContactDrLeslie Edward S Lewis

Kasturba Hospital ,Manipal

leslielewis1@gmail.com9449208476

Outcome results

None listed

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