Impact of Modified Feeding Protocol on Neonatal Outcomes

NCT06246032 | Active Not Recruiting DMC

• 1 other identifier: IRB-PGS-2023-03-443
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Birth Weight; Feeding Disorder Neonatal

Keywords

Feeding protocol; Neonates; Preterm; Very low birthweight; NICU

Outcome Measures

Primary Outcomes (2)

• Length of Stay (LOS)

  Number of days that participant stayed at hospital

  Up to 8 weeks

• Duration of Total Parenteral Nutrition (TPN)

  Number of days that participant received Total Parenteral Nutrition (TPN)

  up to 2 weeks

Secondary Outcomes (2)

• Incidence of Necrotizing Enterocolitis

  Up to 8 weeks

• Incidence of Feeding intolerance

  Up to 8 weeks

Study Arms (2)

Modified feeding Protocol

EXPERIMENTAL

Prospective

Other: Modified feeding Protocol

Current feeding Protocol

NO INTERVENTION

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

Interventions

Modified feeding Protocol OTHER

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

Modified feeding Protocol

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight (\<2000g)
• Gestational Age (\<37 week)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Maternity and Children Hospital

Dammam, Eastern Province, Saudi Arabia

Location

MeSH Terms

Conditions

Premature Birth; Birth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanan AlQahtani, Master

  Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 7, 2024
• Study Start: May 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)