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Early exclusive enteral nutrition for Enteral Nutrition

N/A
Waitlist Available
Led By Belal Alshaikh, MD
Research Sponsored by Belal Alshaikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at discharge from nicu, up to 90 days of life
Awards & highlights

Study Summary

This trial is testing whether starting preterm infants on enteral nutrition from birth results in shorter time to full enteral feed when compared to traditional feeding regimen.

Eligible Conditions
  • Enteral Nutrition

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at discharge from nicu, up to 90 days of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and at discharge from nicu, up to 90 days of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration to achieve of full enteral feeds in days
Secondary outcome measures
Feeding intolerance
Incidence of NEC
Incidence of hypoglycemia
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Exclusive Enteral NutritionExperimental Treatment1 Intervention
Feeds will start at least at 80% of reference daily fluid intake from day one of life. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feed.
Group II: Conventional Enteral NutritionActive Control1 Intervention
Infants will be fed as per current Neonatal Intensive Care Unit feeding tables: Infants with birth weight 1000-1500 g will be fed on 15-20 ml/kg human milk in day one. Feeds will be advanced by 15-20 ml/kg per day on second day onwards until infant reaches full enteral feeds. Infants with birth weight >1500 g will be started on 20-30 ml/kg per day on day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feeds.

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Who is running the clinical trial?

Belal AlshaikhLead Sponsor
3 Previous Clinical Trials
179 Total Patients Enrolled
Belal Alshaikh, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Early Exclusive Enteral Nutrition in Early Preterm Infants
Belal Alshaikh 2019. "Early Exclusive Enteral Nutrition in Early Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03708068.
~11 spots leftby Apr 2025
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