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A study to compare the difference in growth and body composition status at discharge in very preterm babies who were given early exclusive enteral nutrition with babies who were given conventional nutrition

A Randomized Controlled Trial of Early Exclusive Enteral Nutrition vs. Conventional Nutrition in 28-31 + 6 Weeks of Gestation Preterm Neonates and Its Effects on Growth and Body Composition at Discharge - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096117
Enrollment
200
Registered
2025-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Early exclusive enteral nutrition from day 1 of life if abdominal examination is normal. : either mother milk or donor human milk will be given Intervention will be started within 2 ho

Sponsors

Dr Viswanadhula S L V Bhargav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 28+0-31+6 weeks GA gestation neonates, whose abdominal examination is normal and ready to be initiated on feeds and admitted to the neonatal unit

Exclusion criteria

Exclusion criteria: Major Congenital malformation and syndromic babies Surgical conditions of the abdomen where feeding can’t be initiated Absent or Reverse end-diastolic flow (AEDForREDF) Severe perinatal asphyxia Refusal of donor human milk Hemodynamic instability within 2 hours of birth Less than 1 kg at birth

Design outcomes

Secondary

MeasureTime frame
Anthropometry in both groups at time of discharge - weight, length, head circumferenceTimepoint: in this study anthropometry will be taken at the time of discharge. there is no specific timepoint for discharge. so we cant determine a specific timepoint;Anthropometry (weight, length, head circumference in both groups as per AGA & SGA subgroups at the time of discharge Timepoint: in this study anthropometry will be taken at the time of discharge. there is no specific timepoint for discharge. so we cant determine a specific timepoin;Time taken to achieve full feeds in 2 groups (150 ml per kg per day) Timepoint: It is the duration by which baby will be accepting full feeds. There is no specific time point;Incidence of culture-positive sepsis in both groups Timepoint: ;Incidence of feed intolerance and NEC grade 2 and above during hospital stay Timepoint: ;All-cause mortalityTimepoint: ;Length of hospital stayTimepoint: ;Incidence of BPD, Anemia, NEC, Osteopenia of prematurity Timepoint: ;Number of babies required TPN during hospital stay Timepoint:

Primary

MeasureTime frame
1)Proportion of EUGR in 2 groups 2)Body composition at discharge or at 37-40 week PMA Timepoint: there is no specific time point to assess the outcome. It is done at discharge.Discharge can be done at 34-37 weeks PMA to preterm babies usually

Countries

India

Contacts

Public ContactDr Kanya Mukhopadhyay

Postgraduate Institute of Medical Education and Research, Chandigarh

kanyapgi@gmail.com7013493522

Outcome results

None listed

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