Skip to content

A study in preterm infants born before 34 weeks comparing nucleotide enriched and conventional human milk fortifiers to assess feeding tolerance and growth.

A Randomized Control Trial Comparing Nucleotide enriched HMF and Conventional HMF in Preterm Infants Less Than 34 Weeks: Effects on Feed tolerance and Growth Accretion. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/107023
Enrollment
124
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Nucleotide Enriched Human Milk Fortifier: Preterm infants will receive human milk fortified with a nucleotide-enriched human milk fortifier. The fortifier will be added to human milk in

Sponsors

NICE Hospital For Women, Newborn And Children Hyderabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates less than thirty four weeks gestation. Birth weight less than two kilograms. Receiving enteral feeding with human milk. Parental informed consent obtained.

Exclusion criteria

Exclusion criteria: Neonates with major congenital gastrointestinal malformations Neonates with severe congenital heart disease or other life threatening congenital anomalies. Neonates with severe intrauterine growth restriction (IUGR) [defined as birth weight ,with abnormal doppler [AEDF/REDF]. Neonates deemed unlikely to survive or for whom exclusive parenteral nutrition is anticipated. Neonates who had undergone surgery under anesthesia.

Design outcomes

Primary

MeasureTime frame
Growth Accretion: Weight gain measured in grams per kilogram per day from birth until discharge or 36 weeks postmenstrual age whichever is earlier.Timepoint: From birth until discharge or 36 weeks postmenstrual age whichever is earlier

Secondary

MeasureTime frame
Incidence of feeding intolerance.Timepoint: During hospitalization from initiation of feeds until discharge.;Time to achieve full enteral feeds defined as one hundred fifty milliliters per kilogram per day.Timepoint: During NICU stay until achievement of full feeds.;Time to regain birth weight.Timepoint: From birth until regain of birth weight.;Other growth parametersTimepoint: Weekly measurements of head circumference and length. ;Incidence of necrotizing enterocolitis stage two or higher and late onset sepsis.Timepoint: During hospitalization.

Countries

India

Contacts

Public ContactDr Vinay V Kulkarni

NICE Hospital For Women, Newborn And Children

lgvinayk2211@gmail.com9878951448

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026