Impact of Modified Feeding Protocol on Neonatal Outcomes

Imam Abdulrahman Bin Faisal University

Status: Active, not recruiting

Conditions: Feeding Disorder Neonatal; Birth Weight; Preterm

Treatments: Other: Modified feeding Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06246032

IRB-PGS-2023-03-443

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Modified feeding Protocol

Experimental group

Description:

Prospective

Treatment:

Other: Modified feeding Protocol

Current feeding Protocol

No Intervention group

Description:

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