search
Back to results

Evaluation of Gastric Residuals and Feedings Progression (REGAP)

Primary Purpose

Infant, Premature, Diseases, Nutrition, Enteral

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Aspiration of gastric residuals
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Premature, Diseases

Eligibility Criteria

1 Hour - 48 Hours (Child)All SexesDoes not accept 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

Sites / Locations

  • Pontificia Universidad Católica de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Routine aspiration of gastric residuals

No aspiration of gastric residuals

Arm 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.

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

Outcomes

Primary Outcome Measures

Time to reach full feeds
Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2019
Last Updated
June 9, 2021
Sponsor
Pontificia Universidad Catolica de Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT04064398
Brief Title
Evaluation of Gastric Residuals and Feedings Progression
Acronym
REGAP
Official Title
Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does it Have on Feedings Progression?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Nutrition, Enteral

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine aspiration of gastric residuals
Arm Type
Active Comparator
Arm 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.
Arm Title
No aspiration of gastric residuals
Arm Type
No Intervention
Arm Description
Infants will not have routine aspiration of gastric contents prior to each feeding.
Intervention Type
Procedure
Intervention Name(s)
Aspiration of gastric residuals
Intervention 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.
Primary Outcome Measure Information:
Title
Time to reach full feeds
Description
Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Fabres, MD, MSPH
Phone
562-23543887
Email
jfabres@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Salas, MD
Phone
562-23543887
Email
valentina.salasb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina A Salas, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge G Fabres, MD, MSPH
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Study Director
Facility Information:
Facility Name
Pontificia Universidad Católica de Chile
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330077
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Fabres, MD, MSPH
Phone
562-23543887
Email
jfabres@gmail.com
First Name & Middle Initial & Last Name & Degree
Valentina Salas, MD
Phone
562-23543887
Email
valentina.salasb@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Gastric Residuals and Feedings Progression

We'll reach out to this number within 24 hrs