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Gastric Residuals in Preterm Infants

Primary Purpose

Early Enteral Feeding Advancement, Nutrition, Preterm Infants

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No check of gastric residuals for early enteral feeding advancement
Routine check of gastric residuals for early enteral feeding advancement
Sponsored by
McMaster Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Enteral Feeding Advancement

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants with a birth weight ≥ 1500g and < 2000g
  • Age ≤48 hours of life
  • Informed, written parental consent

Exclusion Criteria:

  • Antenatally recognized gastrointestinal malformation
  • Major congenital anomaly
  • Chromosomal anomaly
  • NEC stage II
  • Severe acidosis, asphyxia (pH <7.0)
  • Severe growth restriction below 3rd percentile

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No routine check for gastric residuals

Routine check for gastric residuals

Arm Description

Outcomes

Primary Outcome Measures

Time to reach full enteral feeding
Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.

Secondary Outcome Measures

growth, tolerance, morbidity
Time to regain birth weight and maintain weight gain. Incidence of sepsis from birth until 48 hours after parenteral nutrition was administered. Use of antibiotics. Incidence of feeding intolerance and necrotizing enterocolitis.

Full Information

First Posted
April 15, 2011
Last Updated
March 26, 2015
Sponsor
McMaster Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01337622
Brief Title
Gastric Residuals in Preterm Infants
Official Title
Gastric Residuals in Preterm Infants (GRIP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Enteral Feeding Advancement, Nutrition, Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No routine check for gastric residuals
Arm Type
Experimental
Arm Title
Routine check for gastric residuals
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
No check of gastric residuals for early enteral feeding advancement
Intervention Description
Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.
Intervention Type
Procedure
Intervention Name(s)
Routine check of gastric residuals for early enteral feeding advancement
Intervention Description
Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.
Primary Outcome Measure Information:
Title
Time to reach full enteral feeding
Description
Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.
Time Frame
from inclusion (during first 48h of life) until 1 month
Secondary Outcome Measure Information:
Title
growth, tolerance, morbidity
Description
Time to regain birth weight and maintain weight gain. Incidence of sepsis from birth until 48 hours after parenteral nutrition was administered. Use of antibiotics. Incidence of feeding intolerance and necrotizing enterocolitis.
Time Frame
from inclusion (during first 48h of life) until one month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants with a birth weight ≥ 1500g and < 2000g Age ≤48 hours of life Informed, written parental consent Exclusion Criteria: Antenatally recognized gastrointestinal malformation Major congenital anomaly Chromosomal anomaly NEC stage II Severe acidosis, asphyxia (pH <7.0) Severe growth restriction below 3rd percentile
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumesh Thomas, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29866595
Citation
Singh B, Rochow N, Chessell L, Wilson J, Cunningham K, Fusch C, Dutta S, Thomas S. Gastric Residual Volume in Feeding Advancement in Preterm Infants (GRIP Study): A Randomized Trial. J Pediatr. 2018 Sep;200:79-83.e1. doi: 10.1016/j.jpeds.2018.04.072. Epub 2018 Jun 1.
Results Reference
derived

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Gastric Residuals in Preterm Infants

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