Gastric Residuals in Preterm Infants

NCT ID: NCT01337622

Last Updated: 2015-03-30

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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Checking of gastric residuals prior to the continuation/increase of enteral feeding prolongs the time to establish full gastric feeding in the early postnatal period.

Detailed Description

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Conditions

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Early Enteral Feeding Advancement Nutrition Preterm Infants

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 routine check for gastric residuals

Group Type EXPERIMENTAL

No check of gastric residuals for early enteral feeding advancement

Intervention Type PROCEDURE

Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.

Routine check for gastric residuals

Group Type ACTIVE_COMPARATOR

Routine check of gastric residuals for early enteral feeding advancement

Intervention Type PROCEDURE

Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.

Interventions

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No check of gastric residuals for early enteral feeding advancement

Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.

Intervention Type PROCEDURE

Routine check of gastric residuals for early enteral feeding advancement

Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infants with a birth weight ≥ 1500g and \< 2000g
* Age ≤48 hours of life
* Informed, written parental consent

Exclusion Criteria

* Antenatally recognized gastrointestinal malformation
* Major congenital anomaly
* Chromosomal anomaly
* NEC stage II
* Severe acidosis, asphyxia (pH \<7.0)
* Severe growth restriction below 3rd percentile
Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christoph Fusch

Division head NICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumesh Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Singh B, Rochow N, Chessell L, Wilson J, Cunningham K, Fusch C, Dutta S, Thomas S. Gastric Residual Volume in Feeding Advancement in Preterm Infants (GRIP Study): A Randomized Trial. J Pediatr. 2018 Sep;200:79-83.e1. doi: 10.1016/j.jpeds.2018.04.072. Epub 2018 Jun 1.

Reference Type DERIVED
PMID: 29866595 (View on PubMed)

Other Identifiers

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201101GRIP

Identifier Type: -

Identifier Source: org_study_id

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