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Evaluation of Gastric Residuals and Feedings Progression

NCT ID: NCT04064398

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Infant, Premature, Diseases Nutrition, Enteral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Routine 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.

Group Type ACTIVE_COMPARATOR

Aspiration of gastric residuals

Intervention Type PROCEDURE

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

No aspiration of gastric residuals

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valentina A Salas, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Jorge G Fabres, MD, MSPH

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Locations

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Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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190321007

Identifier Type: -

Identifier Source: org_study_id