Evaluation of Gastric Residuals and Feedings Progression (REGAP)

Pontificia Universidad Catolica de Chile

Status: Unknown

Conditions: Infant, Premature, Diseases; Nutrition, Enteral

Treatments: Procedure: Aspiration of gastric residuals

Study type: Interventional

Funder types: Other

Identifiers

NCT04064398

190321007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 1 to 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Routine aspiration of gastric residuals

Active Comparator group

Description:

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

Treatment:

Procedure: Aspiration of gastric residuals

No aspiration of gastric residuals

No Intervention group

Description:

Infants will not have routine aspiration of gastric contents prior to each feeding.