Exclusive Enteral Nutrition in Preterm Neonates

Overview

To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

Full Title of Study: “Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: None (Open Label)
• Study Primary Completion Date: September 12, 2022

Detailed Description

Qualifying participants will be randomly assigned to one of two study groups: 1) Exclusive Enteral Feeds or 2) Progressive Enteral Feeds with supplemental parenteral nutrition. Regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned. Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved. Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved. If parent agrees, stool "dirty" diapers will be collected 2 times during this study. One time around the time of birth and one time at 28 days or discharge (whichever occurs first).

Interventions

• Procedure: Exclusive Enteral Nutrition
  • Mom’s milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
• Procedure: Progressive Enteral Nutrition
  • Mom’s milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

Arms, Groups and Cohorts

• Experimental: Exclusive Enteral Nutrition
  • This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.
• Active Comparator: Progressive Enteral Nutrition
  • This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.

Clinical Trial Outcome Measures

Primary Measures

• Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
  • Time Frame: Birth to 28 days
  • Days of full feeds in the first 28 days after birth

Secondary Measures

• Time to establish full enteral feeding
  • Time Frame: Birth to 28 days
  • Time interval between birth and full enteral feeding at 150ml/kg/day
• Number of episodes of feeding intolerance
  • Time Frame: Birth to 28 days
  • Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
• Number of days receiving parenteral nutrition and IV fluids
  • Time Frame: Birth to 28 days
• Number of days receiving central line access
  • Time Frame: Birth to 28 days
• Number of episodes of culture proven sepsis
  • Time Frame: Birth to 60 days or discharge, whichever occurs first
  • Positive blood cultures
• Number of participants with diagnosis of necrotizing enterocolitis
  • Time Frame: Birth to 60 days or discharge, whichever occurs first
  • Diagnosis of necrotizing enterocolitis stage 2 or 3
• Number of participants with diagnosis of intestinal perforation
  • Time Frame: Birth to 14 days
  • Pneumoperitoneum on abdominal radiograph
• Death
  • Time Frame: Birth to 60 days
• Weight
  • Time Frame: Birth to 60 days
  • Weekly measurements of weight in g
• Length
  • Time Frame: Birth to 60 days
  • Weekly measurements of length in cm
• Head circumference
  • Time Frame: Birth to 60 days
  • Weekly measurements of head circumference in cm
• Duration of hospital stay in days
  • Time Frame: Birth to 60 days

Participating in This Clinical Trial

Inclusion Criteria

• Gestational age between 28 and 32 weeks of gestation Exclusion Criteria:

• Intrauterine growth restriction (birth weight < 10th percentile) – Major congenital or chromosomal anomalies – Terminal illness in which decisions to withhold or limit support have been made

Gender Eligibility: All

Minimum Age: 1 Hour

Maximum Age: 48 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Alabama at Birmingham
• Provider of Information About this Clinical Study
  • Principal Investigator: Ariel A. Salas, Assistant Professor – University of Alabama at Birmingham
• Overall Official(s)
  • Vivek Shukla, MD, Study Chair, University of Alabama at Birmingham
  • Ariel Salas, MD, MSPH, Study Director, University of Alabama at Birmingham
  • Jacqueline Razzaghy, MD, Principal Investigator, University of Alabama at Birmingham