Evaluation of Gastric Residuals and Feedings Progression

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04064398

Acronym

REGAP

Enrollment

203

Registered

2019-08-21

Start date

2019-10-14

Completion date

2024-08-31

Last updated

2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature, Diseases, Nutrition, Enteral

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.

Interventions

PROCEDUREAspiration 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 48 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026