Study Stopped
The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.
Evaluation of Gastric Residuals and Feedings Progression
REGAP
1 other identifier
interventional
203
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 11, 2024
December 1, 2024
4.9 years
August 19, 2019
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 8 weeks
Study Arms (2)
Routine aspiration of gastric residuals
ACTIVE COMPARATORInfants 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 INTERVENTIONInfants will not have routine aspiration of gastric contents prior to each feeding.
Interventions
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330077, Chile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentina A Salas, MD
Pontificia Universidad Catolica de Chile
- STUDY DIRECTOR
Jorge G Fabres, MD, MSPH
Pontificia Universidad Catolica de Chile
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
October 14, 2019
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share