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

Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965769
• Other study ID #: 2011-216
• Secondary ID: Gerber003
• Status: Completed
• Phase: N/A
• First received: October 15, 2013
• Last updated: October 15, 2013
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

Other:
• No gastric residual evaluation
Infants will not receive routine gastric residual evaluation prior to feeding.

Locations

Country	Name	City	State
United States	UF & Shands Hospital	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of feeding intake at 2 weeks		Baseline to 2 weeks	No
Secondary	Days to 120 mL/kg/d of enteral feedings		Baseline to approximately 21 days	No
Secondary	Days of parenteral nutrition		Baseline to approximately 21 days	No
Secondary	Incidence of late onset sepsis		Baseline to approximately 90 days	No
Secondary	Weekly or biweekly liver function tests	Direct bilirubin	Baseline to 42 days	No
Secondary	Growth indices	Weight, length and head circumference	Baseline to approximately 90 days	No
Secondary	Length of hospital stay		Baseline to approximately 90 days	No
Secondary	Incidence of necrotizing enterocolitis		Baseline to approximately 90 days	Yes
Secondary	Days requiring a central venous line		Baseline to approximately 21 days	No