Impact of Modified Feeding Protocol on Neonatal Outcomes

February 3, 2024 updated by: Hanan AlQahtani, Imam Abdulrahman Bin Faisal University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Eastern
      • Dammam, Eastern, Saudi Arabia
        • Maternity and Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified feeding Protocol
Prospective
Other: Modified feeding Protocol

Initiation of feeding (fixed): 10cc/kg

Advancement based on birthweight (fixed):

<750g: 15cc/kg/d 750-999g: 20cc/kg/d 1000-1249g: 25cc/kg/d 1250-1499g: 25cc/kg/d 1500-1749g: 35cc/kg/d 1750-2000g: 35cc/kg/d

Starting Human milk fortification when feed reach at 70cc/kg/d
No Intervention: Current feeding Protocol

Retrospective data will be collected from medical record of patients undergo the current feeding protocol as follow

Initiation of feeding (average):

8.7cc/kg (6-12cc/kg)

Advancement based on birthweight (average):

<750g: 20cc/kg/d (17-24cc/kg/d) 750-999g: 29cc/kg/d (25-34cc/kg/d) 1000-1249g: 22cc/kg/d (20-24cc/kg/d) 1250-1499g: 24cc/kg/d (21-25cc/kg/d) 1500-1749g: 20cc/kg/d (18-21cc/kg/d) 1750-2000g: 34cc/kg/d (32-36cc/kg/d)

Starting Human milk fortification when feed reach at 120cc/kg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay (LOS)
Time Frame: Up to 8 weeks
Number of days that participant stayed at hospital
Up to 8 weeks
Duration of Total Parenteral Nutrition (TPN)
Time Frame: up to 2 weeks
Number of days that participant received Total Parenteral Nutrition (TPN)
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Necrotizing Enterocolitis
Time Frame: Up to 8 weeks
Stage 2, Stage 3
Up to 8 weeks
Incidence of Feeding intolerance
Time Frame: Up to 8 weeks
abdominal grith more than 2 cm, gastric residual 50% of the last feed.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Hanan AlQahtani, Master, Imam Abdulrahman Bin Faisal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-PGS-2023-03-443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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