Comparison of Early Versus Late Trophic Feeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Very Low Birth Weight Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early trophic feeding group

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

Group Type EXPERIMENTAL

Early trophic feeding

Intervention Type DIETARY_SUPPLEMENT

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

Late trophic feeding group

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

Group Type EXPERIMENTAL

Late trophic feeding

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Early trophic feeding

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

Intervention Type DIETARY_SUPPLEMENT

Late trophic feeding

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No