Clinical trial NCT00365703: Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
Official title: Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Infant, Premature
Tube feeding
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-08-17
Enrollment: 115
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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)

Primary outcomes:
measure: The mean post conceptual age at which the infant is fed orally only.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Neonatal intensive care unit, Hille Yaffe medical center
Study officials:
affiliation: Hillel Yaffe medical cenetr, Hadera, Israel
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
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