Impact of Modified Feeding Protocol on Neonatal Outcomes

Not Applicable

Active, not recruiting

• Conditions: Preterm; Birth Weight; Feeding Disorder Neonatal
• Interventions: Other: Modified feeding Protocol

• Registration Number: NCT06246032
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2024-01-05
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-03
• Last Update Submitted: 2024-02-03
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified feeding Protocol	Modified feeding Protocol	Prospective

Primary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	Up to 8 weeks	Number of days that participant stayed at hospital
Duration of Total Parenteral Nutrition (TPN)	up to 2 weeks	Number of days that participant received Total Parenteral Nutrition (TPN)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maternity and Children Hospital; 🇸🇦 Dammam, Eastern, Saudi Arabia