The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

Study Overview
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Brief Summary
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This clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement. Healthy preterm infants who are transitioning from gavage to oral feedings via oral intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier gestational age than infants feeding with indwelling tubes and may be ready for earlier discharge.

Detailed Description
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Independent feeding is often one of the last competencies that the premature infant must accomplish prior to discharge from hospital. Feeding is a complex task for the premature infant to accomplish and it often takes many weeks for the infant to learn how to feed. Therefore, tube feeding is required for the infant to ingest adequate nutrition during the transition from gavage feeding to oral feeding. Both intermittent oral gavage tube placement and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants. However, it is not known which tube feeding method will support an expedited transition to oral feeding. The choice of using one method over the other is currently based on the individual health care provider's opinion or historical institutional practices and insufficient evidence is available to guide tube feeding practices.

Official Title
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The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

Conditions
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Premature Infants

Intervention / Treatment
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* Procedure: Indwelling nasogastric tube placement
* Procedure: Intermittent orogastric tube placement
* Device: Nasogastric tube
* Device: Oral gastric tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature infants born between 30-33 and 6/7th weeks gestation are an appropriate size for gestational age, are not on Oxygen are of any race, sex and require tube feeding and are less than 34 and 3/7th weeks gestation. Exclusion Criteria: infants with neurological abnormalities or insults, IVH greater than a grade of two, PVL, birth asphyxia, seizures, cord has less than 7.0 ph, chest compressions, infants who require abstinence scoring, infants with major congenital anomalies or major genetic anomalies that impact feeding ability such as diaphragmatic hernia and cleft palate, major cardiac defects, infants who develop necrotizing enterocolitis, infants who received more than 14 days of intubation or CPAP or oxygen by nasal prongs and infants of diabetic or alcoholic mothers.

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indwelling nasogastric tube placement<br> | Procedure: Indwelling nasogastric tube placement<br>* The premature infant is fed with an indwelling nasogastric tube during feeding transition.<br>* Other names: Nasogastric tube;Device: Nasogastric tube<br>* Premature infants will be fed with a nasogastric tube in place and their feeding behaviors will be noted till discharge.<br>|
| Active Comparator: Intermittent orogastric tube placement<br> | Procedure: Intermittent orogastric tube placement<br>* The premature infant is fed with an intermittently placed orogastric tube during feeding transition.<br>* Other names: Oral gastric tube;Device: Oral gastric tube<br>* Premature infants will be fed with intermittent orogastric tube placement and their feeding behaviors will be noted till discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age of the last required tube feed. |  | Last required tube feed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge date |  | Discharge date | 
| The amount suckled per day |  | Discharge date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tube feeding, premature infant