Comparison of Early Versus Late Trophic Feeding

NCT07229885 | Completed

• 1 other identifier: Dr-Nadeem-Nishter
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce. Therefore, the current study was planned with the objective of comparing the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay.

Conditions

Very Low Birth Weight Infant

Outcome Measures

Primary Outcomes (1)

• Incidence of necrotizing enterocolitis

  Confirmation of the occurrence of necrotizing enterocolitis based on modified Bell's diagnostic criteria

  Up to 30 days

Secondary Outcomes (1)

• Hospital stay

  through study completion, an average of 1 month

Study Arms (2)

Early trophic feeding group

EXPERIMENTAL

Infants will receive trophic (enteral) feeding within the first 48 hours after birth.

Dietary Supplement: Early trophic feeding

Late trophic feeding group

EXPERIMENTAL

Infants will receive trophic (enteral) feeding after 72 hours after birth.

Dietary Supplement: Late trophic feeding

Interventions

Early trophic feeding DIETARY_SUPPLEMENT

Infants will receive trophic (enteral) feeding within the first 48 hours after birth.

Early trophic feeding group

Late trophic feeding DIETARY_SUPPLEMENT

Infants will receive trophic (enteral) feeding within the first 72 hours after birth.

Late trophic feeding group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Any gender
• Neonates aged 1-30 days
• Preterm very low birth weight neonates

You may not qualify if:

• Neonates transferred from other hospital and already started on antibiotics.
• Neonates with congenital anomalies, hypoxic ischemic encephalopathy, central nervous system (CNS) impairment, neonatal sepsis, urinary tract infection, or one of twins or higher order multiples (on history and medical record).
• Non-consenting parents.

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Nishtar Hospital

Multan, Punjab Province, 66000, Pakistan

Location

Study Officials

• Nadeem Akram

  Nishter Hospital Multan, Pakistan

  PRINCIPAL INVESTIGATOR

• Sulaiman Ali, FCPS

  Nishter Hospital Multan, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 17, 2025
• Study Start: May 15, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

PA (1)