Exclusive Enteral Nutrition in Preterm Neonates

N/AActive Not RecruitingNCT04337710

University of Alabama at Birmingham102 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

102

Conditions

Premature; Infant, Light-for-dates Enteral Feeding Intolerance

Interventions

Exclusive Enteral NutritionPROCEDURE

Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.

Progressive Enteral NutritionPROCEDURE

Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

Eligibility

Sex: ALLMin age: 1 HourMax age: 48 Hours

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth

Days of full feeds in the first 28 days after birth

Time frame: Birth to 28 days

Secondary Outcomes

Time to establish full enteral feeding

Time interval between birth and full enteral feeding at 150ml/kg/day

Time frame: Birth to 28 days

Number of episodes of feeding intolerance

Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination

Time frame: Birth to 28 days

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

Positive blood cultures

Time frame: Birth to 60 days or discharge, whichever occurs first

Number of participants with diagnosis of necrotizing enterocolitis

Diagnosis of necrotizing enterocolitis stage 2 or 3

Time frame: Birth to 60 days or discharge, whichever occurs first

Number of participants with diagnosis of intestinal perforation

Pneumoperitoneum on abdominal radiograph

Time frame: Birth to 14 days

Data from ClinicalTrials.gov

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