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

Not Applicable

Completed

• Conditions: Premature Infant
• Interventions: Other: No gastric residual evaluation

• Registration Number: NCT01965769
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-06
• Status Verified: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Last Update Submitted: 2013-10-15
• Study First Posted: 2013-10-18
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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Exclusion Criteria

• Congenital or chromosomal disorders,
• Severe complications leading to death in the first week of life

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no gastric residual evaluation	No gastric residual evaluation	Infants will not receive routine gastric residual evaluation prior to feeding

Primary Outcome Measures

Name	Time	Method
Amount of feeding intake at 2 weeks	Baseline to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Days to 120 mL/kg/d of enteral feedings	Baseline to approximately 21 days
Incidence of late onset sepsis	Baseline to approximately 90 days
Weekly or biweekly liver function tests	Baseline to 42 days	Direct bilirubin
Growth indices	Baseline to approximately 90 days	Weight, length and head circumference
Days of parenteral nutrition	Baseline to approximately 21 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

Trial Locations

Locations (1)

UF & Shands Hospital; 🇺🇸 Gainesville, Florida, United States