Aspiration of Residual Gastric Contents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-07

Study Completion Date

2019-01-22

Brief Summary

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The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.

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Detailed Description

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The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.

Conditions

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Infant, Premature Nutrition, Enteral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Routine aspiration of gastric contents

Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Group Type ACTIVE_COMPARATOR

Routine aspiration of gastric contents

Intervention Type PROCEDURE

Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

No aspiration of gastric contents

Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Group Type EXPERIMENTAL

No aspiration of gastric contents

Intervention Type PROCEDURE

Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Interventions

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No aspiration of gastric contents

Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.

Intervention Type PROCEDURE

Routine aspiration of gastric contents

Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* born at 32 weeks of less of gestational age
* birth weight \</= to 1250 grams
* receiving some enteral feedings by 72 hours of age
* receiving parenteral feedings by 24 hours of age