Evaluation of Gastric Residuals and Feedings Progression

Not Applicable

Terminated

• Conditions: Infant, Premature, Diseases; Nutrition, Enteral
• Interventions: Procedure: Aspiration of gastric residuals

• 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

Arm && Interventions

Group	Intervention	Description
Routine aspiration of gastric residuals	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.

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