Comparison of Early Versus Late Trophic Feeding

Comparison of Early Versus Late Trophic Feeding in Preterm Very Low Birth Weight Neonates at a Tertiary Care Hospital

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.

Study Overview

• Status: Completed
• Conditions: Very Low Birth Weight Infant
• Intervention / Treatment: Dietary supplement: Early trophic feeding; Dietary supplement: Late trophic feeding

Detailed Description

Since preterm, very low birth weight births are common in society, an effective treatment modality is needed at the moment. Evaluating the length of hospital stay and occurrence of necrotizing enterocolitis in preterm very low birth weight neonates with respect to two approaches of trophic feeding in local settings will provide an insight into a better implementation of preventive strategies, resulting in reducing the hospital stays and the incidence of necrotizing enterocolitis, and hence reducing the burden on the already meager resources.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 66000
      • Nishtar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early trophic feeding group; Infants will receive trophic (enteral) feeding within the first 48 hours after birth.	Dietary supplement: Early trophic feeding; Infants will receive trophic (enteral) feeding within the first 48 hours after birth.
Experimental: Late trophic feeding group; Infants will receive trophic (enteral) feeding after 72 hours after birth.	Dietary supplement: Late trophic feeding; Infants will receive trophic (enteral) feeding within the first 72 hours after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of necrotizing enterocolitis	Confirmation of the occurrence of necrotizing enterocolitis based on modified Bell's diagnostic criteria	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Total days from admission till final outcome (discharge/death due to any case).	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: RESnTEC, Institute of Research
• Investigators: Principal Investigator: Nadeem Akram, Nishter Hospital Multan, Pakistan; Study Director: Sulaiman Ali, FCPS, Nishter Hospital Multan, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Dr-Nadeem-Nishter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No