Premature; Infant, Light-for-datesNCT01420263
Re-feeding Gastric Residuals in Preterm Infants
A study testing Re-feeding residuals and Fresh Feeding Breastmilk or Formula only in people with Premature; Infant, Light-for-dates, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk… Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Premature; Infant, Light-for-dates
- What is being tested?
- Re-feeding residuals and Fresh Feeding Breastmilk or Formula only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2013
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 23.0 and 28.6 weeks;
- Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
- Written informed consent from the parents
Who cannot join
- Major congenital/chromosomal anomalies;
- Moribund infant with low likelihood of survival, in the opinion of the clinical team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).
Read the detailed description
Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.
- Conditions
- Premature; Infant, Light-for-dates
- Being tested
- Re-feeding residuals, Fresh Feeding Breastmilk or Formula only
- Keywords
- premature infant, feeding, residuals, fresh feeds, full feeds, digestive system
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-feeding residualsProcedure or surgery
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
Fresh Feeding Breastmilk or Formula onlyProcedure or surgery
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Re-feeding gastric residuals | Active comparator | In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. Receives: Procedure: Re-feeding residuals |
| Fresh feeding breastmilk/formula only | Active comparator | In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. Receives: Procedure: Fresh Feeding Breastmilk or Formula only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to establish full enteral feeding
Time required to reach enteral feeding at 120cc/kg/day
Measured: Birth to 28 days
Secondary outcomes (7)
Feeding intolerance
Feeding intolerance defined as interruption or cessation of enteral feeds for a perod greater than 12 hours for presence of bloody gastric residuals or an abnormal abdominal examination.
Measured: Birth to 28 days
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.
Measured: Birth to 28 days
Number of days receiving parenteral nutrition
Total number of days or partial day receiving parenteral nutrition
Measured: Birth to 28 days
Duration of hospital stay
Length of hospital stay in days
Measured: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV
Measured: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of intestinal perforation
Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.
Measured: Birth to 120 days or discharge, whichever occurs first
Death
Death prior to 121 days of age.
Measured: Birth to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel Salas, MD, University of Alabama at Birmingham
- Investigators
- Ariel A Salas, MD, Principal investigator, University of Alabama at BirminghamNamasivayam Ambalavanan, MD, Study director, University of Alabama at BirminghamWaldemar A Carlo, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420263
- Sponsor's protocol ID
- UAB Neo 004
- Status last verified
- Feb 2013
- First submitted
- 17 Aug 2011
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salas AA, Cuna A, Bhat R, McGwin G Jr, Carlo WA, Ambalavanan N. A randomised trial of re-feeding gastric residuals in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F224-8. doi: 10.1136/archdischild-2014-307067. Epub 2014 Dec 31.
PubMed 25552280
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
- ClinicalTrials.gov ID
- NCT01420263
- Acronym / sponsor ID
- UAB Neo 004
- Conditions
- Premature; Infant, Light-for-dates
- Keywords
- premature infant, feeding, residuals, fresh feeds, full feeds, digestive system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 19 Aug 2011 (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.
The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).
Detailed description
Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-feeding gastric residuals | Active comparator | Procedure: Re-feeding residualsIn the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. |
| Fresh feeding breastmilk/formula only | Active comparator | Procedure: Fresh Feeding Breastmilk or Formula onlyIn the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age between 23.0 and 28.6 weeks;
- Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
- Written informed consent from the parents
Key exclusion criteria (2 listed)
- Major congenital/chromosomal anomalies;
- Moribund infant with low likelihood of survival, in the opinion of the clinical team
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 |
|---|---|---|
| Re-feeding residualsIn the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. | Procedure or surgery | Re-feeding gastric residuals |
| Fresh Feeding Breastmilk or Formula onlyIn the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours. | Procedure or surgery | Fresh feeding breastmilk/formula only |
Primary outcome
Time to establish full enteral feeding
Time frame: Birth to 28 days
Time required to reach enteral feeding at 120cc/kg/day
7 secondary outcomes
Feeding intolerance
Time frame: Birth to 28 days
Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.
Time frame: Birth to 28 days
Number of days receiving parenteral nutrition
Time frame: Birth to 28 days
Duration of hospital stay
Time frame: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of necrotizing enterocolitis
Time frame: Birth to 120 days or discharge, whichever occurs first.
Diagnosis of intestinal perforation
Time frame: Birth to 120 days or discharge, whichever occurs first
Death
Time frame: Birth to 120 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 11 Feb 2013.
- Derived from this study: PubMed 25552280Salas AA, Cuna A, Bhat R, McGwin G Jr, Carlo WA, Ambalavanan N. A randomised trial of re-feeding gastric residuals in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F224-8. doi: 10.1136/archdischild-2014-307067. Epub 2014 Dec 31.
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 principal investigator
University of Alabama at Birmingham
Namasivayam Ambalavanan, MD study director
University of Alabama at Birmingham
Waldemar A Carlo, MD study chair
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 Re-feeding residuals and Fresh Feeding Breastmilk or Formula only 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 3 inclusion and 2 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 11 Feb 2013. 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?
Time to establish 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 NCT01420263, which also lists 1 linked publication.
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 11 Feb 2013.