Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

December 15, 2007 updated by: Hillel Yaffe Medical Center
The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.

There is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.

Development and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Neonatal intensive care unit, Hille Yaffe medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.

Exclusion Criteria:

  • Infants who died during hospitalization
  • Infants with severe neurologic deficit (e.g. after Sarnat II-III asphyxia, or as a part of a syndrome
  • Infants with gastrostomy
  • Infants who were transferred to another hospital for any reason (e.g. heart surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Orogastric feeding tube.
Procedure: Feeding tube insertion
  1. Orogastric feeding tube
  2. Nasogastric feeding tube
Experimental: 2
Nasogastric feeding tube.
Procedure: Feeding tube insertion
  1. Orogastric feeding tube
  2. Nasogastric feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean post conceptual age at which the infant is fed orally only.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Erez Nadir, MD, Hillel Yaffe medical cenetr, Hadera, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 15, 2006

First Submitted That Met QC Criteria

August 15, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 15, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/2006-1-HY-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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