Premature InfantNCT01965769
Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
A study testing No gastric residual evaluation in people with Premature Infant, run by University of Florida at 1 site in United States.
Trial summary
Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Premature Infant
- What is being tested?
- No gastric residual evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 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 Up to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age less than 32 weeks,
- Birth weight less than or equal to 1250 grams,
- Initial feeding tolerated within 48 hours of life
Who cannot join
- Congenital or chromosomal disorders,
- Severe complications leading to death in the first week of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants
Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.
Read the detailed description
Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.
- Conditions
- Premature Infant
- Being tested
- No gastric residual evaluation
- Keywords
- Very low birth weight infants, premature, nutrition, gastric residual
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No gastric residual evaluationOther
Infants will not receive routine gastric residual evaluation prior to feeding.
| Study group | Role | What they receive |
|---|---|---|
| no gastric residual evaluation | Experimental | Infants will not receive routine gastric residual evaluation prior to feeding Receives: Other: No gastric residual evaluation |
| gastric residual evaluation | No intervention | Infants will receive routine gastric residual evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of feeding intake at 2 weeks
Measured: Baseline to 2 weeks
Secondary outcomes (8)
Days to 120 mL/kg/d of enteral feedings
Measured: Baseline to approximately 21 days
Days of parenteral nutrition
Measured: Baseline to approximately 21 days
Incidence of late onset sepsis
Measured: Baseline to approximately 90 days
Weekly or biweekly liver function tests
Direct bilirubin
Measured: Baseline to 42 days
Growth indices
Weight, length and head circumference
Measured: Baseline to approximately 90 days
Length of hospital stay
Measured: Baseline to approximately 90 days
Incidence of necrotizing enterocolitis
Measured: Baseline to approximately 90 days
Days requiring a central venous line
Measured: Baseline to approximately 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Sponsor
- Investigators
- Josef Neu, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965769
- Sponsor's protocol ID
- 2011-216
- Other IDs
- Gerber003
- Status last verified
- Oct 2013
- First submitted
- 15 Oct 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01965769
- Acronym / sponsor ID
- 2011-216
- Conditions
- Premature Infant
- Keywords
- Very low birth weight infants, premature, nutrition, gastric residual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 2013 (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.
Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.
Detailed description
Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no gastric residual evaluation | Experimental | Other: No gastric residual evaluationInfants will not receive routine gastric residual evaluation prior to feeding |
| gastric residual evaluation | No intervention | –Infants will receive routine gastric residual evaluation |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age less than 32 weeks,
- Birth weight less than or equal to 1250 grams,
- Initial feeding tolerated within 48 hours of life
Key exclusion criteria (2 listed)
- Congenital or chromosomal disorders,
- Severe complications leading to death in the first week of life
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 |
|---|---|---|
| No gastric residual evaluationInfants will not receive routine gastric residual evaluation prior to feeding. | Other | no gastric residual evaluation |
Primary outcome
Amount of feeding intake at 2 weeks
Time frame: Baseline to 2 weeks
8 secondary outcomes
Days to 120 mL/kg/d of enteral feedings
Time frame: Baseline to approximately 21 days
Days of parenteral nutrition
Time frame: Baseline to approximately 21 days
Incidence of late onset sepsis
Time frame: Baseline to approximately 90 days
Weekly or biweekly liver function tests
Time frame: Baseline to 42 days
Growth indices
Time frame: Baseline to approximately 90 days
Length of hospital stay
Time frame: Baseline to approximately 90 days
Incidence of necrotizing enterocolitis
Time frame: Baseline to approximately 90 days
Days requiring a central venous line
Time frame: Baseline to approximately 21 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 18 Oct 2013.
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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.
Josef Neu, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No gastric residual evaluation in people with Premature Infant, run by University of Florida 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 18 Oct 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?
Amount of feeding intake at 2 weeks (time frame: Baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2013.