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NCT04064398 Clinical Trial

Evaluation of Gastric Residuals and Feedings Progression

Infant, Premature, Diseases Clinical Trial

— REGAP  

Official title:
Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does it Have on Feedings Progression?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04064398
Other study ID # 190321007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date December 31, 2022

Study information
Verified date May 2021
Source Pontificia Universidad Catolica de Chile
Contact Jorge Fabres, MD, MSPH
Phone 562-23543887
Email jfabres@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 48 Hours
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Aspiration of gastric residuals
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Locations
Country Name City State
Chile Pontificia Universidad Católica de Chile Santiago Región Metropolitana

Sponsors (1)
Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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