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Evaluation of Gastric Residuals and Feedings Progression (REGAP)

P

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)

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.

Trial contacts and locations

1

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Central trial contact

Jorge Fabres, MD, MSPH; Valentina Salas, MD

Data sourced from clinicaltrials.gov

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