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

NCT ID: NCT01965769

Last Updated: 2013-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-10-31

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.

Conditions

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Premature Infant

Keywords

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Very low birth weight infants premature nutrition gastric residual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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no gastric residual evaluation

Infants will not receive routine gastric residual evaluation prior to feeding

Group Type EXPERIMENTAL

No gastric residual evaluation

Intervention Type OTHER

Infants will not receive routine gastric residual evaluation prior to feeding.

gastric residual evaluation

Infants will receive routine gastric residual evaluation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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No gastric residual evaluation

Infants will not receive routine gastric residual evaluation prior to feeding.

Intervention Type OTHER

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
Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josef Neu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF & Shands Hospital

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Gerber003

Identifier Type: OTHER

Identifier Source: secondary_id

2011-216

Identifier Type: -

Identifier Source: org_study_id