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Effect of aggressive nutrition strategies on neurodevelopment of preterm babies

Change in intact outcome of Very Low Birth Weight babies after implementation of early aggressive nutrition strategy.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009818
Enrollment
260
Registered
2017-09-18
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- Inborn Preterm neonates less than or equal to 32 weeks gestation and less than or equal to 1500 gm. Observational study.

Interventions

None listed

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn preterm babies born at less than or equal to 32 weeks gestation AND less than equal to 1500 grams - enrollment on the first day of life itself

Exclusion criteria

Exclusion criteria: 1.Babies 2.Proven intra uterine infection 3.Major congenital malformations 4.HIV positive mothers 5.Need for extensive resuscitation at birth ( chest compression/medication)

Design outcomes

Primary

MeasureTime frame
Difference in proportion of preterm very low birth weight (VLBW) babies with intact outcomes [survival without major Neurodevelopment Disability (NDD) and chronic lung disease of prematurity (CLD) at 12 months of age, corrected for prematurity] in babies managed in two time epochs, before (historical cohort); and after (study cohort) introduction of early aggressive nutrition strategies.Timepoint: 12 months of age, corrected for prematurity

Secondary

MeasureTime frame
Difference in proportion of babies diagnosed to have NECTimepoint: During hospital stay;Difference in proportion of babies diagnosed to have ROP requiring laser therapyTimepoint: As per the ROP screening protocol;Difference in proportion of babies diagnosed to have sepsisTimepoint: During hospital stay;Difference in proportion of babies having Grade 3 or 4 IVH /PVL at term corrected age.Timepoint: Term corrected age

Countries

India

Contacts

Public ContactDr Swati Upadhyay

Kerala Institute of Medical Sciences, Trivandrum

naveen_19572@hotmail.com

Outcome results

None listed

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