Text Size

Gastric Residuals in Preterm Infants

This study is currently recruiting participants.
Verified June 2012 by McMaster Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Christoph Fusch, McMaster Children's Hospital
ClinicalTrials.gov Identifier:
NCT01337622
First received: April 15, 2011
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Early Enteral Feeding Advancement
Nutrition
Preterm Infants
 Procedure: No check of gastric residuals for early enteral feeding advancement
Procedure: Routine check of gastric residuals for early enteral feeding advancement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gastric Residuals in Preterm Infants (GRIP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster Children's Hospital:

Primary Outcome Measures:
  • Time to reach full enteral feeding [ Time Frame: from inclusion (during first 48h of life) until 1 month ] [ Designated as safety issue: No ]
    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 Frame: from inclusion (during first 48h of life) until one month ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 86
Study Start Date: March 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337622

Contacts
Contact: Sumesh Thomas, MD spthomas@mcmaster.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Sumesh Thomas, MD     +1 (905) 521 2100 ext 76959     spthomas@mcmaster.ca    
Contact: Niels Rochow, MD     +1 (905) 521 2100 ext 75721     rochow@mcmaster.ca    
Principal Investigator: Balpreet Singh, MD            
Sub-Investigator: Niels Rochow, MD            
Sub-Investigator: Christoph Fusch, MD,PhD,FRCPC            
Sub-Investigator: Sladjana Bulatovic-Stajkovic, MD            
Sub-Investigator: Kathy Cunningham            
Sub-Investigator: Loraine Chessell            
Sub-Investigator: Jennifer Wilson            
Sub-Investigator: Michael Marrin, MD            
Sub-Investigator: Prashant Murthy, MD            
Principal Investigator: Sumesh Thomas, MD            
Sponsors and Collaborators
McMaster Children's Hospital
Investigators
Principal Investigator: Sumesh Thomas, MD McMaster University
  More Information

No publications provided

Responsible Party: Christoph Fusch, Division head NICU, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01337622     History of Changes
Other Study ID Numbers: 201101GRIP
Study First Received: April 15, 2011
Last Updated: June 7, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 23, 2013