Exclusive Enteral Nutrition in Preterm Neonates

Enteral Feeding Intolerance Clinical Trial

— ENACT  

Official title:

Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04337710
• Other study ID #: 300004922
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: July 2025
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2023 Dec 22:fetalneonatal-2023-325969. doi: 10.1136/archdischild-2023-325969. Online ahea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal microbiome profile	Determined by molecular analyses of bacterial fragments in fecal samples	At postnatal day 14
Other	Fat-free mass z score	Determined by air-displacement plethysmography	At postnatal day 14
Primary	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	Birth to 28 days
Secondary	Time to establish full enteral feeding	Time interval between birth and full enteral feeding at 150ml/kg/day	Birth to 28 days
Secondary	Number of episodes of feeding intolerance	Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination	Birth to 28 days
Secondary	Number of days receiving parenteral nutrition and IV fluids		Birth to 28 days
Secondary	Number of days receiving central line access		Birth to 28 days
Secondary	Number of episodes of culture proven sepsis	Positive blood cultures	Birth to 60 days or discharge, whichever occurs first
Secondary	Number of participants with diagnosis of necrotizing enterocolitis	Diagnosis of necrotizing enterocolitis stage 2 or 3	Birth to 60 days or discharge, whichever occurs first
Secondary	Number of participants with diagnosis of intestinal perforation	Pneumoperitoneum on abdominal radiograph	Birth to 14 days
Secondary	Death		Birth to 60 days
Secondary	Weight	Weekly measurements of weight in g	Birth to 60 days
Secondary	Length	Weekly measurements of length in cm	Birth to 60 days
Secondary	Head circumference	Weekly measurements of head circumference in cm	Birth to 60 days
Secondary	Duration of hospital stay in days		Birth to 60 days

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