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

This study has been completed.
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00365703
First received: August 15, 2006
Last updated: December 15, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Infant, Premature
Procedure: Feeding tube insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • The mean post conceptual age at which the infant is fed orally only. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: September 2006
Study Completion Date: August 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365703

Locations
Israel
Neonatal intensive care unit, Hille Yaffe medical center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Erez Nadir, MD Hillel Yaffe medical cenetr, Hadera, Israel
  More Information

Publications:

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00365703     History of Changes
Other Study ID Numbers: 17/2006-1-HY-CTIL
Study First Received: August 15, 2006
Last Updated: December 15, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Infant, Premature
Tube feeding

ClinicalTrials.gov processed this record on July 20, 2014