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Study of outcomes in preterm babies who are fed with Mothers own milk (MOM) and Pasteurised Donor human milk(PDHM) ( the milk obtained from human milk bank) against babies who are fed with Mothers own milk with preterm formula .

Comparison of enteral feeding regimen using Mothers own milk (MOM) with Pasteurized Donor human milk(PDHM) vs Mothers own milk(MOM) with preterm formula ((PTF) on composite outcome of infection or NEC(Necrotizing Enterocolitis) or mortality in babies born between 28 to 34 weeks of gestation- An open label randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016480
Enrollment
428
Registered
2018-11-30
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: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Mothers own milk plus Pasteurised donor human milk (PDHM): ( Mothers own milk )MOM: Mothers own milk, expressed by mothers of respective babies under all sterile condition Pasteurized

Sponsors

Dept of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn preterm neonates with gestation age between 28 to 34 weeks of gestation and admitted to Nursery and NN ward of Lady Hardinge medical college with no contraindications for enteral feeding from admission and without any conditions mentioned in exclusion criteria.

Exclusion criteria

Exclusion criteria: 1.Babies born less than 28 weeks and more than 34 weeks 2.Severe Birth Asphyxia 3.Respiratory distress severe enough requiring Invasive mechanical ventilation 4.Shock ( Hemodynamic instability at admission) 5.Absent end diastolic flow (AEDF) or Reversed end diastolic flow ( REDF) in umbilical artery Doppler flow study antenatally. 6.major congenital anomalies or birth defects 7.Antenatally diagnosed or suspected congenital infection TORCH [toxoplasma- sis, other (syphilis, varicella-zoster, parvovirus B19), rubella, cytomegalovirus, and herpes infection]) 8.Babies born at the time when Pasteurized donor human milk or preterm formula feeds cannot be provided 9.Refusal to give consent for participation in to the study

Design outcomes

Primary

MeasureTime frame
1.Babies will be assessed for any symptoms and signs of feed intolerance or NEC 2.Babies will be assessed for Clinical sepsis/ culture proven sepsis 3.All cause mortality Timepoint: From admission till discharge of the neonate from Neonatal ward or Nursery—

Secondary

MeasureTime frame
â?¢To compare the proportion of babies with rehospitalisation from all causes . Timepoint: from discharge till 3 months of chronological age;To compare growth in terms of weight length and OFC in babies receiving MOM plus PDHM vs MOM plus Formula feed until 3 months of chronological age. Timepoint: Weight is monitored once daily from admission till discharge, and then weekly till 3 months of chronological age at follow up. Length and OFC ( occipito-frontal circumference ) is measured at admission and then weekly till 3 months of chronological age;To compare the proportion of preterm babies with early comorbidities of prematurity i.e. anaemia of prematurity, osteopenia of prematurity, retinopathy of prematurity. Timepoint: At 4 weeks of chrological age (routinely )or earlier if symptoms and signs of anemia occur to screen for anemia of prematurity At 4 weeks of chrological age or earlier if symptoms and signs of ostopenia occur to screen for ostopenia of prematurity 3. All babies will under go ROP screening at 4 weeks of chronological age—

Countries

India

Contacts

Public ContactDr Sushma Nangia

Lady Hardinge Medical College

drsushmanangia@gmail.com9810838181

Outcome results

None listed

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