Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS

Study Overview
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Brief Summary
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Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.

Detailed Description
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Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.

Official Title
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Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants

Conditions
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Premature Infant

Intervention / Treatment
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* Other: No gastric residual evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age less than 32 weeks, Birth weight less than or equal to 1250 grams, Initial feeding tolerated within 48 hours of life Exclusion Criteria: Congenital or chromosomal disorders, Severe complications leading to death in the first week of life

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no gastric residual evaluation<br>Infants will not receive routine gastric residual evaluation prior to feeding | Other: No gastric residual evaluation<br>* Infants will not receive routine gastric residual evaluation prior to feeding.<br>|
| No Intervention: gastric residual evaluation<br>Infants will receive routine gastric residual evaluation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of feeding intake at 2 weeks |  | Baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to 120 mL/kg/d of enteral feedings |  | Baseline to approximately 21 days | 
| Days of parenteral nutrition |  | Baseline to approximately 21 days | 
| Incidence of late onset sepsis |  | Baseline to approximately 90 days | 
| Weekly or biweekly liver function tests | Direct bilirubin | Baseline to 42 days | 
| Growth indices | Weight, length and head circumference | Baseline to approximately 90 days | 
| Length of hospital stay |  | Baseline to approximately 90 days | 
| Incidence of necrotizing enterocolitis |  | Baseline to approximately 90 days | 
| Days requiring a central venous line |  | Baseline to approximately 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very low birth weight infants, premature, nutrition, gastric residual