Nasogastric/Oral Gastric Tube Placement in Infants: Comparing 2 Measurement Methods
Tracking Information | |||||
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First Received Date ICMJE | July 25, 2011 | ||||
Last Updated Date | March 29, 2012 | ||||
Start Date ICMJE | July 2011 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method [ Time Frame: Participants will be followed for the duration of hospitalization, an average expected time of 4 weeks. Once an OG/NG tube change is completed per study protocol the participant will have completed the study. ] [ Designated as safety issue: Yes ] During the same day of NG/OG tube placement, verification of placement will be performed by bedside nurse as per institutional standards. X-ray verification will be done in batches (not same day) and read by radiologist blind to insertion method. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01407991 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method [ Time Frame: X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks. ] [ Designated as safety issue: Yes ] Radiologist blinded to the randomized method of insertion will determine location of placement. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Nasogastric/Oral Gastric Tube Placement in Infants: Comparing 2 Measurement Methods | ||||
Official Title ICMJE | Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods | ||||
Brief Summary | The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube placement for efficacy and safety in the placement of NG/OG tube in infants less than 6 months of age. One method is based on the infant's length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method) and the other method is based on current standard of care, measuring from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how far to insert the tube. Outcome comparison will be xray verification of placement. |
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Detailed Description | Preterm infants often require nutritional intake through a nasogastric or oral gastric tube to meet their high energy requirement and avoid aspiration of nutrition due to their immature suck/swallow reflex. When providing nutrition via an NG or OG tube, there are two basic safety issues; accurate placement, determined by the end of the tube reaching the mid abdominal area, and verification methods to assure placement is optimal. Based on a review of relevant literature, a potentially more accurate method of tube placement is available than the method used in current practice. We hypothesize the graph method will result in a more accurate and less variable placement of the NG tube into the mid-stomach of preterm infants than the current standard using the NEM method. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
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Condition ICMJE | Enteral Tube Placement | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | Klasner AE, Luke DA, Scalzo AJ. Pediatric orogastric and nasogastric tubes: a new formula evaluated. Ann Emerg Med. 2002 Mar;39(3):268-72. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 72 | ||||
Estimated Completion Date | August 2013 | ||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | up to 6 Months | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01407991 | ||||
Other Study ID Numbers ICMJE | 10-007863 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Elizabeth Ely, Children's Hospital of Philadelphia | ||||
Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Children's Hospital of Philadelphia | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |