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Clinical Trials/NCT06246032
NCT06246032
Active, not recruiting
Not Applicable

Impact of Modified Feeding Protocol on Neonatal Outcomes

Imam Abdulrahman Bin Faisal University1 site in 1 country30 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm
Sponsor
Imam Abdulrahman Bin Faisal University
Enrollment
30
Locations
1
Primary Endpoint
Length of Stay (LOS)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.

The main questions it aims to answer are:

  • Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?
  • Is Modified feeding protocol feasible, efficient, and safe in preterm infants?

Participants will undergo the modified feeding protocol since birth until discharge.

Detailed Description

two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate The outcomes of both group will be compeered to meet the study objectives

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hanan AlQahtani

Clinical Dietitian

Imam Abdulrahman Bin Faisal University

Eligibility Criteria

Inclusion Criteria

  • Birth weight (\<2000g)
  • Gestational Age (\<37 week)

Exclusion Criteria

  • Metabolic Disorders
  • Congenital Heart Diseases
  • Chronic Lung Disease
  • Congenital Anomalies (can related to feeding)
  • Moderate to severe GERD
  • Necrotizing enterocolitis stage 3 (surgical)
  • Gastrointestinal surgery

Outcomes

Primary Outcomes

Length of Stay (LOS)

Time Frame: Up to 8 weeks

Number of days that participant stayed at hospital

Duration of Total Parenteral Nutrition (TPN)

Time Frame: up to 2 weeks

Number of days that participant received Total Parenteral Nutrition (TPN)

Secondary Outcomes

  • Incidence of Feeding intolerance(Up to 8 weeks)
  • Incidence of Necrotizing Enterocolitis(Up to 8 weeks)

Study Sites (1)

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