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Effect of differtent quantity of oral protein on growth and brain development in premature babies

IMPACT OF DIFFERENTIAL ENTERAL PROTEIN INTAKE ON GROWTH AND NEURODEVELOPMENT IN PRETERM INFANTS LESS THAN 32 WEEKS.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/06/004661
Enrollment
120
Registered
2014-06-10
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- Preterm babies less than 32 weeks or 1.5 Kg

Interventions

Intervention1: High protein HMF: High protein HMF as compared to available HMF.Contains additional 1 gm protein per 100 ml of EBM.Given mixed with human milk orally every 2 hourly till baby is dischar

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies admitted to SGRH who are less than 1500 gms or less than 32 weeks of gestation. On 100 ml/kg feeds

Exclusion criteria

Exclusion criteria: Lethal congenital malformations diagnosed before enrollment

Design outcomes

Primary

MeasureTime frame
Head circumference gain (cm/week) at discharge, 40 weeks of corrected gestational age, 6 months and 12 months corrected age.Timepoint: Head circumference gain (cm/week) at discharge, 40 weeks of corrected gestational age, 6 months and 12 months corrected age.

Secondary

MeasureTime frame
1. Growth assessed by a)Weight gain (g/kg/day) b)Length gain (cm/week) c)Proportion of infants who are small for gestational age 2. Neurodevelopmental outcomes assessed by DASII(Developmental assessment scale for Indian Infants)at 1 year of age 3.Safety as assessed by Blood urea nitrogen levels (mmol/l), Plasma Prealbumin levels (g/l),levels which are routinely done as per unit protocol. 4.Sepsis: incidence and number of episodes (confirmed by blood culture Timepoint: At discharge, 40 weeks of corrected gestational age,6 months and 12 months corrected age.

Countries

India

Contacts

Public ContactDrNeelam Kler

Sir Ganga Ram hospital

drneelamkler@gmail.com9811047391

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 28, 2026