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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06246032
Other study ID # IRB-PGS-2023-03-443
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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