Infant, Premature, DiseasesREGAPNCT04064398
Evaluation of Gastric Residuals and Feedings Progression
A study testing Aspiration of gastric residuals in people with Infant, Premature, Diseases and Nutrition, Enteral, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Infant, Premature, Diseases, Nutrition, Enteral
- What is being tested?
- Aspiration of gastric residuals
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteChile
- Study dates
- 14 Oct 2019to 31 Aug 2024
- 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 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age.
- Enteral feeds starting during the first week of life.
- Signed informed consent from parents or guardians.
Who cannot join
- Perinatal asphyxia
- Sepsis and hemodynamic instability
- Major congenital malformations
- Surgical requirement during the first week of life
- Hemodynamic instability and vasoactive drugs requirement
- Moderate or severe respiratory failure with Oxygenation Index > 8
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330077
About this study
Official title: Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does It Have on Feedings Progression?
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.
Read the detailed description
The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.
Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.
- Conditions
- Infant, Premature, Diseases, Nutrition, Enteral
- Being tested
- Aspiration of gastric residuals
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration of gastric residualsProcedure or surgery
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Routine aspiration of gastric residuals | Active comparator | Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. Receives: Procedure: Aspiration of gastric residuals |
| No aspiration of gastric residuals | No intervention | Infants will not have routine aspiration of gastric contents prior to each feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach full feeds
Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start14 Oct 2019
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina A Salas, MD, Principal investigator, Pontificia Universidad Catolica de ChileJorge G Fabres, MD, MSPH, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064398
- Sponsor's protocol ID
- 190321007
- Acronym
- REGAP
- Status last verified
- Dec 2024
- First submitted
- 19 Aug 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does It Have on Feedings Progression?
- ClinicalTrials.gov ID
- NCT04064398
- Acronym / sponsor ID
- REGAP / 190321007
- Conditions
- Infant, Premature, Diseases, Nutrition, Enteral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Aug 2019 (actual)
- 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.
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.
Detailed description
The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.
Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine aspiration of gastric residuals | Active comparator | Procedure: Aspiration of gastric residualsInfants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. |
| No aspiration of gastric residuals | No intervention | –Infants will not have routine aspiration of gastric contents prior to each feeding. |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age.
- Enteral feeds starting during the first week of life.
- Signed informed consent from parents or guardians.
Key exclusion criteria (6 listed)
- Perinatal asphyxia
- Sepsis and hemodynamic instability
- Major congenital malformations
- Surgical requirement during the first week of life
- Hemodynamic instability and vasoactive drugs requirement
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 |
|---|---|---|
| Aspiration of gastric residualsInfants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. | Procedure or surgery | Routine aspiration of gastric residuals |
Primary outcome
Time to reach full feeds
Time frame: Baseline to 8 weeks
Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.
Results and safety
The study was stopped early (reason given: The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Valentina A Salas, MD principal investigator
Pontificia Universidad Catolica de Chile
Jorge G Fabres, MD, MSPH study director
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration of gastric residuals in people with Infant, Premature, Diseases and Nutrition, Enteral, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 6 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: stopped early, as of the sponsor's last update on 11 Dec 2024. 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 Chile. 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 was stopped early (reason given: The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.). Results are not available in the source record.
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 reach full feeds (time frame: Baseline to 8 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 11 Dec 2024.