Evaluation of Gastric Residuals and Feedings Progression

Not Applicable

Terminated

• Conditions: Infant, Premature, Diseases; Nutrition, Enteral

• Registration Number: NCT04064398
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

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 Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-10-14
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 203

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to reach full feeds	Baseline to 8 weeks	Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.

Trial Locations

Locations (1)

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile