Impact of Modified Feeding Protocol on Neonatal Outcomes

Preterm Clinical Trial

Official title:

Impact of Modified Feeding Protocol on Neonatal Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06246032
• Other study ID #: IRB-PGS-2023-03-443
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Preterm

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children Hospital	Dammam	Eastern

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay (LOS)	Number of days that participant stayed at hospital	Up to 8 weeks
Primary	Duration of Total Parenteral Nutrition (TPN)	Number of days that participant received Total Parenteral Nutrition (TPN)	up to 2 weeks
Secondary	Incidence of Necrotizing Enterocolitis	Stage 2, Stage 3	Up to 8 weeks
Secondary	Incidence of Feeding intolerance	abdominal grith more than 2 cm, gastric residual 50% of the last feed.	Up to 8 weeks