- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02915549
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.
Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.
Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.
Both groups will receive fast progressive feeding (>/= 24 ml/kg/day)
If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35249
- University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks
Exclusion Criteria:
- small for gestational age (<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision to withhold or limit support have been made
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Progressive Feeding without MEF
This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
|
This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
|
Active Comparator: Progressive Feeding with MEF
This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
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This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days alive and receiving full enteral feeding
Time Frame: birth to 28 days
|
number of days alive on full enteral feeding in the first 28 days after birth
|
birth to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with diagnosis of necrotizing enterocolitis
Time Frame: birth to 120 days or discharge, whichever occurs first
|
diagnosis of necrotizing enterocolitis stage 2 or 3
|
birth to 120 days or discharge, whichever occurs first
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Number of participants with diagnosis of intestinal perforation
Time Frame: birth to 14 days
|
birth to 14 days
|
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Death
Time Frame: birth to 120 days
|
death prior to 121 days of birth
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birth to 120 days
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Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days
Time Frame: birth to 28 days
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birth to 28 days
|
|
Time to establish full enteral feeding
Time Frame: birth to 28 days
|
time interval between birth and full enteral feeding at 120cc/kg/day
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birth to 28 days
|
Number of episodes of feeding intolerance
Time Frame: birth to 28 days
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interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
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birth to 28 days
|
Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours
Time Frame: birth to 28 days
|
birth to 28 days
|
|
Number of days receiving parenteral nutrition
Time Frame: birth to 28 days
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birth to 28 days
|
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Number of days requiring central line access
Time Frame: birth to 28 days
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birth to 28 days
|
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Number of episodes of culture proven sepsis
Time Frame: birth to 120 days or discharge, whichever occurs first
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birth to 120 days or discharge, whichever occurs first
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|
Growth/length at time of discharge
Time Frame: birth to 120 days or discharge, whichever occurs first
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birth to 120 days or discharge, whichever occurs first
|
|
Duration of hospital stay in days
Time Frame: birth to 120 days or discharge, whichever occurs first
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birth to 120 days or discharge, whichever occurs first
|
|
Changes in intestinal microbiome
Time Frame: birth to 28 days
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Determined by molecular analyses of bacteria in fecal samples
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birth to 28 days
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Salas AA, Li P, Parks K, Lal CV, Martin CR, Carlo WA. Early progressive feeding in extremely preterm infants: a randomized trial. Am J Clin Nutr. 2018 Mar 1;107(3):365-370. doi: 10.1093/ajcn/nqy012.
- Salas AA, Willis KA, Carlo WA, Yi N, Zhang L, Van Der Pol WJ, Younge NE, Lefkowitz EJ, Lal CV. The gut microbiome of extremely preterm infants randomized to the early progression of enteral feeding. Pediatr Res. 2022 Sep;92(3):799-804. doi: 10.1038/s41390-021-01831-w. Epub 2021 Nov 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F160609004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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