Gastric Residuals in Preterm Infants

March 26, 2015 updated by: Christoph Fusch, McMaster Children's Hospital

Gastric Residuals in Preterm Infants (GRIP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No routine check for gastric residuals
Procedure: No check of gastric residuals for early enteral feeding advancement
Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.
Active Comparator: Routine check for gastric residuals
Procedure: Routine check of gastric residuals for early enteral feeding advancement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach full enteral feeding
Time Frame: from inclusion (during first 48h of life) until 1 month
Full enteral feeding is defned as an milk intake of equal or more than 120 ml/kg/d.
from inclusion (during first 48h of life) until 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth, tolerance, morbidity
Time Frame: from inclusion (during first 48h of life) until one month

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.
from inclusion (during first 48h of life) until one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster Children's Hospital

Investigators

  • Principal Investigator: Sumesh Thomas, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201101GRIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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