Premature; Infant, Light-for-datesNCT02915549
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
A study testing Progressive Feeding without MEF and Progressive Feeding with MEF in people with Premature; Infant, Light-for-dates, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk. Read more about this study
- Who is it for?
- Ages 24 to 48 hours
- Conditions the study is for
- Premature; Infant, Light-for-dates
- What is being tested?
- Progressive Feeding without MEF and Progressive Feeding with MEF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.
Read the 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).
- Conditions
- Premature; Infant, Light-for-dates
- Being tested
- Progressive Feeding without MEF, Progressive Feeding with MEF
- Keywords
- premature infant, early progressive feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Feeding without MEFOther
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.
Progressive Feeding with MEFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Feeding without MEF | Experimental | 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. Receives: Other: Progressive Feeding without MEF |
| Progressive Feeding with MEF | Active comparator | 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. Receives: Other: Progressive Feeding with MEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days alive and receiving full enteral feeding
number of days alive on full enteral feeding in the first 28 days after birth
Measured: birth to 28 days
Secondary outcomes (13)
Number of participants with diagnosis of necrotizing enterocolitis
diagnosis of necrotizing enterocolitis stage 2 or 3
Measured: birth to 120 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Measured: birth to 14 days
Death
death prior to 121 days of birth
Measured: birth to 120 days
Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days
Measured: birth to 28 days
Time to establish full enteral feeding
time interval between birth and full enteral feeding at 120cc/kg/day
Measured: 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
Measured: 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
Measured: birth to 28 days
Number of days receiving parenteral nutrition
Measured: birth to 28 days
Number of days requiring central line access
Measured: birth to 28 days
Number of episodes of culture proven sepsis
Measured: birth to 120 days or discharge, whichever occurs first
Growth/length at time of discharge
Measured: birth to 120 days or discharge, whichever occurs first
Duration of hospital stay in days
Measured: birth to 120 days or discharge, whichever occurs first
Changes in intestinal microbiome
Determined by molecular analyses of bacteria in fecal samples
Measured: birth to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Ariel A. Salas, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915549
- Sponsor's protocol ID
- F160609004
- Status last verified
- Dec 2022
- First submitted
- 19 Sep 2016
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 29529231Salas 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.
PubMed 34775476Durham L, Gunawan E, Nguyen K, Reeves A, Shukla V, Salas AA. Total Fluid Administration and Weight Loss during the First 2 Weeks in Infants Randomized to Early Enteral Feeding after Extremely Preterm Birth. Neonatology. 2023;120(2):257-262. doi: 10.1159/000527430. Epub 2022 Nov 28.
PubMed 36442467
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02915549
- Acronym / sponsor ID
- F160609004
- Conditions
- Premature; Infant, Light-for-dates
- Keywords
- premature infant, early progressive feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Feeding without MEF | Experimental | Other: Progressive Feeding without MEFThis 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. |
| Progressive Feeding with MEF | Active comparator | Other: Progressive Feeding with MEFThis 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. |
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Feeding without MEFThis 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. | Other | Progressive Feeding without MEF |
| Progressive Feeding with MEFThis 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. | Other | Progressive Feeding with MEF |
Primary outcome
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
13 secondary outcomes
Number of participants with diagnosis of necrotizing enterocolitis
Time frame: birth to 120 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Time frame: birth to 14 days
Death
Time frame: birth to 120 days
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
Time to establish full enteral feeding
Time frame: birth to 28 days
Number of episodes of feeding intolerance
Time frame: 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
Number of days receiving parenteral nutrition
Time frame: birth to 28 days
Number of days requiring central line access
Time frame: birth to 28 days
Number of episodes of culture proven sepsis
Time frame: birth to 120 days or discharge, whichever occurs first
Growth/length at time of discharge
Time frame: 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
Changes in intestinal microbiome
Time frame: birth to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Results publication: PubMed 29529231Salas 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.
- Results publication: PubMed 34775476Salas 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.
- Results publication: PubMed 36442467Durham L, Gunawan E, Nguyen K, Reeves A, Shukla V, Salas AA. Total Fluid Administration and Weight Loss during the First 2 Weeks in Infants Randomized to Early Enteral Feeding after Extremely Preterm Birth. Neonatology. 2023;120(2):257-262. doi: 10.1159/000527430. Epub 2022 Nov 28.
- Individual participant dataSharing planned: No
Related trials for Premature; Infant, Light-for-dates
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel A. Salas, MD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Feeding without MEF and Progressive Feeding with MEF in people with Premature; Infant, Light-for-dates, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days alive and receiving full enteral feeding (time frame: birth to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915549, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.