Trial to find out effect of two breastmilk fortifying methods- preterm infant formula versus commercially available fortifier, on weight gain among preterm as well as small for gestational age neonates

EFFECT OF FORTIFICATION OF BREASTMILK WITH PRE-TERM FORMULA (PTF) VERSUS HUMAN MILK FORTIFIER (HMF) ON WEIGHT GAIN IN PRETERM SMALL FOR GESTATIONAL AGE NEONATES: A RANDOMIZED CONTROLLED TRIAL - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103579

Enrollment

110

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: E640- Sequelae of protein-calorie malnutrition

Interventions

Intervention1: Fortification with PTF : In the PTF group, 1 g of preterm formula powder will be added to every 25 ml of expressed breast milk (EBM). Sachets containing the prescribed quantity of PT

Eligibility

Inclusion criteria

Inclusion criteria: All neonates with gestational age less than 34 weeks and small for gestational age baby on predominant breastmilk feeds - at least 75 percent breastmilk with total feed volume of 100 ml per kg per day

Exclusion criteria

Exclusion criteria: Major congenital anomalies, Chromosomal anomalies, NEC, IVH, Exclusively formula fed neonates

Design outcomes

Primary

Measure	Time frame
weight gain - g per kg per dayTimepoint: daily, with trend calculated and compared at 40 weeks postmenstrual age or discharge, whichever is earlier	—

Secondary

Measure	Time frame
other anthropometric measures - 1. Length 2. Head Circumference (HC) 3. Skin fold thickness (STF) 4. Body mass index (BMI) Timepoint: weekly & trend compared at 40w PMA or discharge, whichever is earlier;Body composition by DEXA (for a sub-group reaching 40w PMA during hospital stay) 1. Fat mass 2. Lean mass 3. Bone mineral concentration (BMC) 4. Bone mineral density (BMD)Timepoint: at 40w PMA;co- morbidities - 1.Sepsis, Necrotising Enterocolitis (NEC), Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD), Intraventricular Haemorrhage (IVH) 2. Feed intolerance 3. Mortality 4. Extrauterine Growth Restriction (EUGR) Timepoint: at 40w PMA or discharge or death, whichever is earlier	—

Measure

Time frame

other anthropometric measures - 1. Length 2. Head Circumference (HC) 3. Skin fold thickness (STF) 4. Body mass index (BMI) Timepoint: weekly & trend compared at 40w PMA or discharge, whichever is earlier;Body composition by DEXA (for a sub-group reaching 40w PMA during hospital stay) 1. Fat mass 2. Lean mass 3. Bone mineral concentration (BMC) 4. Bone mineral density (BMD)Timepoint: at 40w PMA;co- morbidities - 1.Sepsis, Necrotising Enterocolitis (NEC), Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD), Intraventricular Haemorrhage (IVH) 2. Feed intolerance 3. Mortality 4. Extrauterine Growth Restriction (EUGR) Timepoint: at 40w PMA or discharge or death, whichever is earlier

—

Countries

India

Contacts

Public ContactDR SUMAN CHAURASIA

AIIMS, Rishikesh

rebellionbrdwj16@gmail.com7251919518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026