Clinical trial NCT04337710: Exclusive Enteral Nutrition in Preterm Neonates
Official title: Exclusive Enteral Nutrition in Preterm Neonates- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature; Infant, Light-for-dates
Enteral Feeding Intolerance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
timeFrame: Birth to 28 days
Secondary outcomes:
measure: Time to establish full enteral feeding
timeFrame: Birth to 28 days
measure: Number of episodes of feeding intolerance
timeFrame: Birth to 28 days
measure: Number of days receiving parenteral nutrition and IV fluids
timeFrame: Birth to 28 days
measure: Number of days receiving central line access
timeFrame: Birth to 28 days
measure: Number of episodes of culture proven sepsis
timeFrame: Birth to 60 days or discharge, whichever occurs first
measure: Number of participants with diagnosis of necrotizing enterocolitis
timeFrame: Birth to 60 days or discharge, whichever occurs first
measure: Number of participants with diagnosis of intestinal perforation
timeFrame: Birth to 14 days
measure: Death
timeFrame: Birth to 60 days
measure: Weight
timeFrame: Birth to 60 days
measure: Length
timeFrame: Birth to 60 days
measure: Head circumference
timeFrame: Birth to 60 days
measure: Duration of hospital stay in days
timeFrame: Birth to 60 days
Other outcomes:
measure: Intestinal microbiome profile
timeFrame: At postnatal day 14
measure: Fat-free mass z score
timeFrame: At postnatal day 14
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Vivek Shukla, MD
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Ariel Salas, MD, MSPH
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Jacqueline Razzaghy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969.