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NCT01337622 Clinical Trial

Gastric Residuals in Preterm Infants

Nutrition Clinical Trial

Official title:
Gastric Residuals in Preterm Infants (GRIP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01337622
Other study ID # 201101GRIP
Secondary ID
Status Completed
Phase N/A
First received April 15, 2011
Last updated March 26, 2015
Start date March 2011
Est. completion date December 2013

Study information
Verified date March 2015
Source McMaster Children's Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 48 Hours
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Canada McMaster Children's Hospital Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to reach full enteral feeding 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 No
Secondary 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.		 from inclusion (during first 48h of life) until one month No
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