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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).

Improved protein fortification of human milk fed to very low birth weight babies :a Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004279
Enrollment
72
Registered
2014-01-03
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- GROWTH OF VERY LOW BIRTH WEIGHT NEWBORNS

Interventions

Intervention1: CONCENTRATED WHEY PROTEIN POWDER : 1 gram of CONCENTRATED WHEY PROTEIN POWDER will be added to every 100 ml of expressed breast milk, already fortified with currently available human m

Sponsors

The Institute of Post Graduate Medical Education Research IPGMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: a. All babies with major congenital anomalies will be excluded. b. Severe gastrointestinal malformations such as Gastroschisis, Omphalocele,Tracheo-Esophageal Fistula or surgical conditions affecting the gastrointestinal tract such as intussusceptions, volvulus, malrotation, meconium ileus etc. or necrotizing enterocolitis . c. Babies being kept NPO for 3 consecutive 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 growth could be monitored for at least a period of 14 days will be excluded from this study.

Design outcomes

Primary

MeasureTime frame
1. weight gain(gram/kg/day) 2. increase in length (cm/week) 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

MeasureTime frame
1. pH and base deficit of the blood 2. Serum BUN 3. serum Creatinine 4. incidence of necrotising enterocolitis and feeding intoleranceTimepoint: at the end of week 1,week 2, week 3 and week 4 of the study

Countries

India

Contacts

Public ContactDr Anshuman Paria

The Institute of Post Graduate Medical Education & Research (IPGMER)

syamalsardar.neo@gmail.com09434306529

Outcome results

None listed

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