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Gastric Residuals in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337622
First Posted: April 19, 2011
Last Update Posted: March 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christoph Fusch, McMaster Children's Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastric Residuals in Preterm Infants (GRIP)

Further study details as provided by Christoph Fusch, 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 ]
    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 ]

    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.



Enrollment: 87
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337622


Locations
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster Children's Hospital
Investigators
Principal Investigator: Sumesh Thomas, MD McMaster University
  More Information

Responsible Party: Christoph Fusch, Division head NICU, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01337622     History of Changes
Other Study ID Numbers: 201101GRIP
First Submitted: April 15, 2011
First Posted: April 19, 2011
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications