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Enteral Nutrition for Premature Birth (ENACT Trial)

N/A
Waitlist Available
Led By Jacqueline Razzaghy, MD
Research Sponsored by University of Alabama at Birmingham
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 birth to 60 days
Awards & highlights

ENACT Trial Summary

This trial is testing whether earlier, exclusive enteral nutrition (through the gut) is better for preterm infants than delayed enteral nutrition and prolonged use of parenteral nutrition (through the veins).

Who is the study for?
This trial is for preterm infants born between 28 and 32 weeks of gestation. It's not suitable for babies with growth restrictions (birth weight below the 10th percentile), major birth defects, or those with terminal illnesses where life support is limited.Check my eligibility
What is being tested?
The study compares two feeding strategies in premature babies: one group will start early on exclusive enteral nutrition (feeding through the gut) minimizing parenteral nutrition (IV feeding), while another group will have a delayed progression to enteral nutrition.See study design
What are the potential side effects?
Potential side effects may include digestive issues related to intolerance of enteral feeding, such as bloating, gas, vomiting, or diarrhea. There might also be risks associated with reduced use of IV nutrition.

ENACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
Secondary outcome measures
Death
Duration of hospital stay in days
Head circumference
+9 more
Other outcome measures
Fat-free mass z score
Intestinal microbiome profile

ENACT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exclusive Enteral NutritionExperimental Treatment1 Intervention
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.
Group II: Progressive Enteral NutritionActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exclusive Enteral Nutrition
2017
N/A
~40

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,256 Total Patients Enrolled
Ariel Salas, MD, MSPHStudy DirectorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
150 Total Patients Enrolled
Vivek Shukla, MDStudy ChairUniversity of Alabama at Birmingham

Media Library

Exclusive Enteral Nutrition Clinical Trial Eligibility Overview. Trial Name: NCT04337710 — N/A
Enteral Feeding Intolerance Research Study Groups: Progressive Enteral Nutrition, Exclusive Enteral Nutrition
Enteral Feeding Intolerance Clinical Trial 2023: Exclusive Enteral Nutrition Highlights & Side Effects. Trial Name: NCT04337710 — N/A
Exclusive Enteral Nutrition 2023 Treatment Timeline for Medical Study. Trial Name: NCT04337710 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age-limit for this research study extend beyond 75 years of age?

"The enrollment criteria for this research dictates that participants must have been born within the last 48 hours, with a minimum age of one hour."

Answered by AI

Who is eligible to take part in this investigative study?

"To be eligible to join this trial, participants must have been born pre-term between 1 Hour and 48 Hours old. This medical research is looking for a collective 102 patients."

Answered by AI

Is enrollment in this research project currently available to participants?

"According to the information available on clinicialtrials.gov, this trial is no longer actively seeking patients for enrollment. Initially posted on May 27th 2021 and last edited October 18th 2022, it appears that recruitment has been paused; however, there are 5 other trials simultaneously engaging with participants at present."

Answered by AI
~27 spots leftby Mar 2025