Gastric Residuals in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01337622|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : March 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gastric Residuals in Preterm Infants (GRIP)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|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.
- 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.
- 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.
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
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Sumesh Thomas, MD||McMaster University|